Biomerica, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biomerica, Inc.” (first 1991, latest 2023), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 94 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 88 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biomerica, Inc. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYR | Helicobacter Pylori | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Microbiology (3)
- Immunology (2)
Most recent Biomerica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232892 | Hp Detect Stool Antigen ELISA | LYR | 2023-12-15 | 88 |
| K003856 | EZ-HCG URINE(PREGNANCY TEST) | JHI | 2001-02-21 | 70 |
| K982954 | FREE T4 MICROWELL EIA, MODEL #7019 | CEC | 1998-09-24 | 31 |
| K962216 | TSH (MICROWELL) ELISA | JLW | 1996-09-19 | 101 |
| K960412 | T-3 MICROWELL EIA MODEL 7013 | CDP | 1996-03-19 | 50 |
| K954256 | ANTI-TPO | JNL | 1995-11-27 | 83 |
| K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 | KLI | 1995-06-29 | 140 |
| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | DDC | 1994-07-18 | 214 |
| K915185 | GAP IGG H.PYLORI MODIFIED | LYR | 1992-03-04 | 107 |
| K900343 | GAP-IGG | LYR | 1991-08-22 | 576 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-09-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
BIOMERICA INC (BMRA): EDGAR filings, CIK 73290. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomerica, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Biomerica, Inc.” (first 1991, latest 2023), across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biomerica, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomerica, Inc. is 94 days.
Which FDA product codes appear under Biomerica, Inc.?
The most frequent FDA product codes under this applicant name are LYR (Helicobacter Pylori, 3); CDP (Radioimmunoassay, Total Triiodothyronine, 1); CEC (Radioimmunoassay, Free Thyroxine, 1).
Next steps
- See all 10 Biomerica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYR, Biomerica, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.