The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek2 Ast-gram Negative Delafloxacin (=4 Ug/ml).
| Device ID | K183524 |
| 510k Number | K183524 |
| Device Name: | VITEK2 AST-Gram Negative Delafloxacin (=4 Ug/mL) |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | bioMerieux, Inc. 595 Anglum Road Hazlewood, MO 63042 |
| Contact | Esther Hernandez |
| Correspondent | Esther Hernandez bioMerieux, Inc. 595 Anglum Road Hazlewood, MO 63042 |
| Product Code | LON |
| Subsequent Product Code | LTT |
| Subsequent Product Code | LTW |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-03-12 |