The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Eravacycline (erv) (0.002 – 32 µg/ml).
Device ID | K192050 |
510k Number | K192050 |
Device Name: | ETEST Eravacycline (ERV) (0.002 – 32 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 | 2019-07-31 |
Decision Date | 2019-09-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026560997 | K192050 | 000 |