K050976 is an FDA 510(k) clearance for the VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE. This device is classified as a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II - Special Controls, product code LON).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 23, 2005, 35 days after receiving the submission on April 18, 2005.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.
| 510(k) Number | K050976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2005 |
| Decision Date | May 23, 2005 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1645 |