- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - Clinical Chemistry devices: recent FDA 510(k) clearances # Clinical Chemistry devices: recent FDA 510(k) clearances **15 clinical Chemistry devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Beta Bionics, Inc. with 2. Data last updated 2026-11-03; each record links to its official source and a full report.** Data as of 2026-11-03 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 15 clinical Chemistry devices: recent FDA 510(k) clearances (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Clinical%20Chemistry&record_type=clearance) 15 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Beta Bionics, Inc. (2). Each record links to a full report and the official source. Last updated 2026-11-03. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?panel=Clinical%20Chemistry&record_type=clearance&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=Clinical%20Chemistry&record_type=clearance) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 15 Most frequent - Beta Bionics, Inc. (2) - Beckman Coulter, Inc. (2) - Becton, Dickinson and Company (1) - EPS Bio Technology Corp. (1) - Sol-Millennium Medical, Inc. (1) ## How do I get new clinical Chemistry devices: recent FDA 510(k) clearances by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?panel=Clinical%20Chemistry&record_type=clearance) [Watch this exact filter](/v/fdapulse?panel=Clinical%20Chemistry&record_type=clearance#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top clinical Chemistry devices: recent FDA 510(k) clearances right now? | Record | Specialty | Type | Date | |---|---|---|---| | BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company | Clinical Chemistry | 510(k) | 2026-10-16 | | EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp. | Clinical Chemistry | 510(k) | 2026-10-23 | | Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc. | Clinical Chemistry | 510(k) | 2026-10-21 | | Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc. | Clinical Chemistry | 510(k) | 2026-09-11 | | CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc. | Clinical Chemistry | 510(k) | 2026-10-02 | | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd. | Clinical Chemistry | 510(k) | 2026-10-09 | | H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd. | Clinical Chemistry | 510(k) | 2026-10-02 | | Mint ACE Pump (K263422): 510(k) cleared for Beta Bionics, Inc. | Clinical Chemistry | 510(k) | 2026-10-21 | | Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. | Clinical Chemistry | 510(k) | 2026-10-20 | | twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. | Clinical Chemistry | 510(k) | 2026-10-15 | | Profoject™ Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd. | Clinical Chemistry | 510(k) | 2026-09-25 | | Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc. | Clinical Chemistry | 510(k) | 2026-09-22 | | Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. | Clinical Chemistry | 510(k) | 2026-09-21 | | Biolinq Shine Autonomous Time-in-Range Microsensor (K262599): 510(k) cleared for Biolinq Incorporated | Clinical Chemistry | 510(k) | 2026-09-18 | | iOS CamAPS FX (K261896): 510(k) cleared for CamDiab | Clinical Chemistry | 510(k) | 2026-09-16 | [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many clinical Chemistry devices: recent FDA 510(k) clearances are listed? 15 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23. ### Can I get alerts for Clinical Chemistry devices: recent FDA 510(k) clearances? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.