The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Gram Positive Ertapenem.
Device ID | K050076 |
510k Number | K050076 |
Device Name: | VITEK 2 GRAM POSITIVE ERTAPENEM |
Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
Contact | Jolyn Tenllado |
Correspondent | Jolyn Tenllado 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 | 2005-01-12 |
Decision Date | 2005-02-18 |
Summary: | summary |