The following data is part of a premarket notification filed by Biomérieux, Inc with the FDA for Vitek 2 Ast-gram Positive Linezolid (=8 µg/ml).
| Device ID | K212849 |
| 510k Number | K212849 |
| Device Name: | VITEK 2 AST-Gram Positive Linezolid (=8 µg/mL) |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | bioMérieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Esther Hernandez |
| Correspondent | Esther Hernandez bioMérieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2022-02-04 |