PMA N50510S130

Device: VITEK 2 GRAM NEGATIVE AST FOR CEFEPIME
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S130
Product code: LTW
Decision date: 2000-05-18
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CEFEPIME AT CONCENTRATIONS OF 2, 8, 16 AND 32 MICROGRAMS/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK 2 SYSTEM.

Current openFDA PMA Record#

Device: VITEK 2 GRAM NEGATIVE AST FOR CEFEPIME
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S130
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-05-18
Decision code: APPR
Date received: 2000-04-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CEFEPIME AT CONCENTRATIONS OF 2, 8, 16 AND 32 MICROGRAMS/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK 2 SYSTEM.