K102668 is an FDA 510(k) clearance for the ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML. This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by BIOMERIEUX (Craponne, FR). The FDA issued a Cleared decision on November 17, 2010, 62 days after receiving the submission on September 16, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K102668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2010 |
| Decision Date | November 17, 2010 |
| Days to Decision | 62 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 |