Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biomerica, Inc. with 10 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Dec 15, 2023: Hp Detect™ Stool Antigen ELISA.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 15, 2023 | Hp Detect™ Stool Antigen ELISAK232892 · LYR | 510(k) clearances |
| Sep 18, 2014 | Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.Class II · A potential issue with false high values. | Device recalls |
| Feb 21, 2001 | EZ-HCG URINE(PREGNANCY TEST)K003856 · JHI | 510(k) clearances |
| Sep 24, 1998 | FREE T4 MICROWELL EIA, MODEL #7019K982954 · CEC | 510(k) clearances |
| Sep 19, 1996 | TSH (MICROWELL) ELISAK962216 · JLW | 510(k) clearances |
| Mar 19, 1996 | T-3 MICROWELL EIA MODEL 7013K960412 · CDP | 510(k) clearances |
| Nov 27, 1995 | ANTI-TPOK954256 · JNL | 510(k) clearances |
| Jun 29, 1995 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0K950588 · KLI | 510(k) clearances |
| Jul 18, 1994 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAYK936010 · DDC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
