PMA N50510S126

Device: VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S126
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 under the tradename Vitek 2 and adds the antibiotic cefazolin at concentrations 4,8,and 16 micrograms per millileter to the Vitek 2 Gram Positive Susceptibility Test System.

Current openFDA PMA Record#

Device: VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S126
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 under the tradename Vitek 2 and adds the antibiotic cefazolin at concentrations 4,8,and 16 micrograms per millileter to the Vitek 2 Gram Positive Susceptibility Test System.