PMA N50510S112

Device: VITEK 2 GRAM NEGATIVE AST FOR TICARCILLIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S112
Product code: LTW
Decision date: 2000-02-01
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: the additioin of the antibiotic ticarcillin at concentrations of 16, 32, and 64mg/ml to the Vitek 2 Gram Negative Susceptibility Test System

Current openFDA PMA Record#

Device: VITEK 2 GRAM NEGATIVE AST FOR TICARCILLIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S112
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-02-01
Decision code: APPR
Date received: 1999-08-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: the additioin of the antibiotic ticarcillin at concentrations of 16, 32, and 64mg/ml to the Vitek 2 Gram Negative Susceptibility Test System