Total clearances
3
2020-05-07 → 2026-04-21
Name variants in FDA filings: bioMérieux SA / Biomérieux SA
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| JWY |
— |
— |
— |
2 |
2026-04-21 |
| PIG |
Acute Kidney Injury Test System |
Class II |
Clinical Chemistry |
1 |
2022-07-08 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-04-21 |
K260447 |
ETEST Gepotidacin (GEP) (0.016-256 µg/mL) |
JWY |
— |
— |
| 2022-07-08 |
K210793 |
VIDAS NEPHROCHECK |
PIG |
Class II |
Clinical Chemistry |
| 2020-05-07 |
K200512 |
ETEST Plazomicin (PLZ) (0.016-256 µg/mL) |
JWY |
— |
— |