Biomérieux
Biomérieux appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 21, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | April 21, 2026 |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | June 12, 2025 |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | October 5, 2023 |
| K210793 | VIDAS NEPHROCHECK | July 8, 2022 |
| K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) | February 4, 2022 |
| K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) | May 7, 2020 |