Company · US
Biomerica, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2023. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LYR | Helicobacter Pylori | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JKR | Radioimmunoassay, Calcitonin | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2023 | K232892 | Hp Detect™ Stool Antigen ELISA Biomerica, Inc. | LYR |
| Feb 21, 2001 | K003856 | EZ-HCG URINE(PREGNANCY TEST) Biomerica, Inc. | JHI |
| Sep 24, 1998 | K982954 | FREE T4 MICROWELL EIA, MODEL #7019 Biomerica, Inc. | CEC |
| Sep 19, 1996 | K962216 | TSH (MICROWELL) ELISA Biomerica, Inc. | JLW |
| Mar 19, 1996 | K960412 | T-3 MICROWELL EIA MODEL 7013 Biomerica, Inc. | CDP |
| Nov 27, 1995 | K954256 | ANTI-TPO Biomerica, Inc. | JNL |
| Jun 29, 1995 | K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 Biomerica, Inc. | KLI |
| Jul 18, 1994 | K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY Biomerica, Inc. | DDC |
| Mar 4, 1992 | K915185 | GAP IGG H.PYLORI MODIFIED Biomerica, Inc. | LYR |
| Aug 22, 1991 | K900343 | GAP-IGG Biomerica, Inc. | LYR |