The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Meropenem/vaborbactam (mev) (0.004/8-64/8 µg/ml).
Device ID | K183031 |
510k Number | K183031 |
Device Name: | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) |
Classification | Manual Antimicrobial Susceptibility Test Systems |
Applicant | bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile, FR 69280 |
Contact | Marine Taravant |
Correspondent | Marine Taravant bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile, FR 69280 |
Product Code | JWY |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-11-01 |
Decision Date | 2019-01-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026623739 | K183031 | 000 |
03573026560690 | K183031 | 000 |