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Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc. vs twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.: FDAPulse comparison

twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.'s review days of 80 is 1.0x Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc.'s 77 (23rd percentile). Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc. is dated 2026-09-22; twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. 2026-10-15.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe

How does Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc. compare to twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.?

FieldInstant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc.twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.
Record510(k) clearance510(k) clearance
510(k) numberK262299K262576
DeviceInstant-View® hCG Combo II Cassette Testtwiist Loop Algorithm
ApplicantAlfa Scientific Designs, Inc.Deka Research and Development Corp.
Specialty / panelClinical ChemistryClinical Chemistry
Product codeJHIQJI
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-07-072026-07-27
Decision date2026-09-222026-10-15
Review time (days)7780
Third-party reviewNoNo
Applicant locationPowat, CA, USManchester, NH, US
amount percentile21st23rd
Predicate Speed & CAPA Advisory Opportunity Score36/10036/100
Peer rank and all 500 records (CSV) 🔒 Click to unlock →
Official source URLs for every peer record 🔒 Click to unlock →

Official records: Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc. · twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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