Biomerica
FDA Regulatory Profile
Biomerica appears in FDA public data with 1 recall, 10 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0467-2015, Class II) was initiated on September 18, 2014. Its most recent 510(k) clearance was granted on December 15, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0467-2015 | Class II | Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative det | September 18, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232892 | Hp Detect Stool Antigen ELISA | December 15, 2023 |
| K003856 | EZ-HCG URINE(PREGNANCY TEST) | February 21, 2001 |
| K982954 | FREE T4 MICROWELL EIA, MODEL #7019 | September 24, 1998 |
| K962216 | TSH (MICROWELL) ELISA | September 19, 1996 |
| K960412 | T-3 MICROWELL EIA MODEL 7013 | March 19, 1996 |
| K954256 | ANTI-TPO | November 27, 1995 |
| K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 | June 29, 1995 |
| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | July 18, 1994 |
| K915185 | GAP IGG H.PYLORI MODIFIED | March 4, 1992 |
| K900343 | GAP-IGG | August 22, 1991 |