The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast-gram Negative Omadacycline (=16 µg/ml).
| Device ID | K213931 |
| 510k Number | K213931 |
| Device Name: | VITEK 2 AST-Gram Negative Omadacycline (=16 µg/mL) |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Contact | Debra Broyles |
| Correspondent | Nathan Hardesty bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-16 |
| Decision Date | 2022-06-03 |