The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Telavancin (tla) (0.002-32 Ug/ml).
| Device ID | K180936 |
| 510k Number | K180936 |
| Device Name: | ETEST Telavancin (TLA) (0.002-32 Ug/mL) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile, FR 69280 |
| Contact | Asa Karlsson |
| Correspondent | Asa Karlsson 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 | 2018-04-10 |
| Decision Date | 2018-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026475352 | K180936 | 000 |