PMA N50510S113

Device: VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S113
Product code: LTW
Decision date: 2000-02-08
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: The addition of the antibiotic streptomycin at a concentration of 1000mg/ml to the Vitek 2 Gram Positive Susceptibility Test System.

Current openFDA PMA Record#

Device: VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S113
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-02-08
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 addition of the antibiotic streptomycin at a concentration of 1000mg/ml to the Vitek 2 Gram Positive Susceptibility Test System.