K212849 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL). This device is classified as a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II - Special Controls, product code LON).
Submitted by Biom?rieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 4, 2022, 150 days after receiving the submission on September 7, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.
| 510(k) Number | K212849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2021 |
| Decision Date | February 04, 2022 |
| Days to Decision | 150 days |
| Submission Type | Special |
| 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 |