K180936 is an FDA 510(k) clearance for the ETEST Telavancin (TLA) (0.002-32 ug/mL). This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Biomerieux S.A. (Marcy-L'Etoile, FR). The FDA issued a Cleared decision on July 3, 2018, 84 days after receiving the submission on April 10, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K180936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2018 |
| Decision Date | July 03, 2018 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JWY - Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |