Total clearances
3
2022-02-04 → 2025-06-12
Name variants in FDA filings: Biomérieux / Biomérieux, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| JWY |
— |
— |
— |
2 |
2025-06-12 |
| LON |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Class II |
Microbiology |
1 |
2022-02-04 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-06-12 |
K250856 |
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) |
JWY |
— |
— |
| 2023-10-05 |
K232395 |
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD |
JWY |
— |
— |
| 2022-02-04 |
K212849 |
VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) |
LON |
Class II |
Microbiology |