The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Imipenem/relebactam (ipr) (0.002/4-32/4 Ug/ml).
| Device ID | K191953 |
| 510k Number | K191953 |
| Device Name: | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 Ug/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 | 2019-07-22 |
| Decision Date | 2019-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026551544 | K191953 | 000 |
| 03573026623753 | K191953 | 000 |