K213931 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL). 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 June 3, 2022, 169 days after receiving the submission on December 16, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.
| 510(k) Number | K213931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2021 |
| Decision Date | June 03, 2022 |
| Days to Decision | 169 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 |