PMA N50510S121

Device: VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S121
Product code: LTW
Decision date: 2000-03-09
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: Approval for the addition of the antibiotic meropenem at concentrations of 0.5, 4, and 16 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.

Current openFDA PMA Record#

Device: VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S121
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-03-09
Decision code: APPR
Date received: 1999-10-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of the antibiotic meropenem at concentrations of 0.5, 4, and 16 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.