K190616 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 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 6, 2019, 87 days after receiving the submission on March 11, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.
| 510(k) Number | K190616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2019 |
| Decision Date | June 06, 2019 |
| Days to Decision | 87 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 |