The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Gram Negative Gatifloxacin.
Device ID | K032788 |
510k Number | K032788 |
Device Name: | VITEK 2 GRAM NEGATIVE GATIFLOXACIN |
Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Applicant | BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2320 |
Contact | Nancy Weaver |
Correspondent | Nancy Weaver BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2320 |
Product Code | LON |
CFR Regulation Number | 866.1645 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-08 |
Decision Date | 2003-11-04 |
Summary: | summary |