PMA N50510S119

Device: VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN/TAZOBACTAM
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S119
Product code: LTW
Decision date: 2000-02-17
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: The addition of the antibiotic piperacillin/tazobactam at concentrations of 4/4, 16/4, and 128/4ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.

Current openFDA PMA Record#

Device: VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN/TAZOBACTAM
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S119
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-02-17
Decision code: APPR
Date received: 1999-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: The addition of the antibiotic piperacillin/tazobactam at concentrations of 4/4, 16/4, and 128/4ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.