The following data is part of a premarket notification filed by Biomerieux, Inc with the FDA for Vitek 2 Ast-gn Cefepime (=32 Ug/ml).
Device ID | K161227 |
510k Number | K161227 |
Device Name: | VITEK 2 AST-GN Cefepime (=32 Ug/mL) |
Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Applicant | BIOMERIEUX, INC 595 ANGLUM RD. Hazelwood, MO 63042 |
Contact | Cherece L. Jones |
Correspondent | Cherece L. Jones BIOMERIEUX, INC 595 ANGLUM RD. 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 | 2016-05-02 |
Decision Date | 2016-07-20 |
Summary: | summary |