The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Streptococcus Penicillin.
Device ID | K112000 |
510k Number | K112000 |
Device Name: | VITEK 2 STREPTOCOCCUS PENICILLIN |
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 | 2011-07-13 |
Decision Date | 2011-10-26 |
Summary: | summary |