Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomerica, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
576 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232892 | Hp Detectâ„¢ Stool Antigen ELISA | Biomerica, Inc. | 2023-12-15 | 88 | 0 |
| K003856 | EZ-HCG URINE(PREGNANCY TEST) | Biomerica, Inc. | 2001-02-21 | 70 | 0 |
| K982954 | FREE T4 MICROWELL EIA, MODEL #7019 | Biomerica, Inc. | 1998-09-24 | 31 | 0 |
| K962216 | TSH (MICROWELL) ELISA | Biomerica, Inc. | 1996-09-19 | 101 | 0 |
| K960412 | T-3 MICROWELL EIA MODEL 7013 | Biomerica, Inc. | 1996-03-19 | 50 | 0 |
| K954256 | ANTI-TPO | Biomerica, Inc. | 1995-11-27 | 83 | 0 |
| K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 | Biomerica, Inc. | 1995-06-29 | 140 | 0 |
| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | Biomerica, Inc. | 1994-07-18 | 214 | 0 |
| K915185 | GAP IGG H.PYLORI MODIFIED | Biomerica, Inc. | 1992-03-04 | 107 | 0 |
| K900343 | GAP-IGG | Biomerica, Inc. | 1991-08-22 | 576 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda