FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc.
FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc. (North Carolina): 510(k) cleared for Baebies, Inc. Its amount of 101 is below the median of 138 (35th percentile). Dated 54 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 101 · 35th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related NC FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261837 |
| Device | FINDER Flu A&B/SARS-CoV-2 Test |
| Applicant | Baebies, Inc. |
| Specialty / panel | Microbiology |
| Product code | QOF |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-02 |
| Decision date | 2026-09-11 |
| Review time (days) | 101 |
| Third-party review | No |
| Applicant location | Durham, NC, US |
| amount percentile | 35th of 414 (median 138, 0.7x median) |
| Peer records CSV (9 NC records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-11
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (NC first): EzSensor HD (K261663) · Endox Test Strips (K263267) · Veritas Shoulder System (K263421) · SAS MIS Pelvic Incidence Rods (K263172) · Class II recall Z-0200-2027 · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc. and 9 North Carolina peers
- North Carolina FDAPulse records like this one: 9
- FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc.'s amount: 35th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every North Carolina peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 101-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc. in North Carolina?
FINDER Flu A&B/SARS-CoV-2 Test (K261837) by Baebies, Inc. was cleared on 2026-09-11 after 101 days of review.
How does FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc. compare to other North Carolina FDAPulse records?
Its amount of 101 is below the median (35th percentile); smaller records often move faster and face less competition. It is 54 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
FINDER Flu A&B/SARS-CoV-2 Test (K261837) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| FINDER Flu A&B/SARS-CoV-2 Test (K261837) | NC | 2026-09-11 |
| B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) | DE | 2026-10-23 |
| Elecsys EBV EBNA IgG (K260221) | IN | 2026-10-02 |
| Elecsys EBV VCA IgG (K260232) | IN | 2026-10-02 |
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- B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
- Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics
- Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics
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