The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast-gram Positive Dalbavancin (= 1 µg/ml).
| Device ID | K190616 |
| 510k Number | K190616 |
| Device Name: | VITEK 2 AST-Gram Positive Dalbavancin (= 1 µg/mL) |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Contact | Cherece L. Jones |
| Correspondent | Cherece L. Jones 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 | 2019-03-11 |
| Decision Date | 2019-06-06 |