K102535 is an FDA 510(k) clearance for the ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 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. (Craponne, FR). The FDA issued a Cleared decision on May 16, 2011, 255 days after receiving the submission on September 3, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K102535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2010 |
| Decision Date | May 16, 2011 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JWY - Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |