The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Telavancin In 0.002-32 Ug/ml And 0.016-256 Ug/ml.
| Device ID | K102535 |
| 510k Number | K102535 |
| Device Name: | ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Contact | Asa Karlsson |
| Correspondent | Asa Karlsson BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2011-05-16 |