PMA N50510S125

Device: VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S125
Product code: LTW
Decision date: 2000-03-31
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: This device will be marketed as Vitek 2 which tests for the antibiotic ampicillin/sulbactam at concentrations of 4/2, 8/4, 16/8 and 64/32 micrograms per milliliter.

Current openFDA PMA Record#

Device: VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S125
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-03-31
Decision code: APPR
Date received: 1999-10-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: This device will be marketed as Vitek 2 which tests for the antibiotic ampicillin/sulbactam at concentrations of 4/2, 8/4, 16/8 and 64/32 micrograms per milliliter.