The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast-gram Negative Imipenem (= 16 Ug/ml).
Device ID | K183415 |
510k Number | K183415 |
Device Name: | VITEK 2 AST-Gram Negative Imipenem (= 16 Ug/mL) |
Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Applicant | bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
Contact | Craig Buehler |
Correspondent | Craig Buehler bioMerieux, Inc. 595 Anglum Road Hazelwood, 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 | 2018-12-10 |
Decision Date | 2019-02-20 |