PMA N50510S110

Device: VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S110
Product code: LTW
Decision date: 2000-01-31
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: Approval is for the addition of the antibiotic norfloxacin at concentrations of 0.5, 1 and 4ug/ml to the Vitek 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek 2 and is indicated for use in Vitek 2 Gram Positive Susceptibility Cards for the susceptibility testing of gram positive organism to norfloxacin in the range of <= 0.25 to >=16ug/ml.

Current openFDA PMA Record#

Device: VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S110
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-01-31
Decision code: APPR
Date received: 1999-08-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval is for the addition of the antibiotic norfloxacin at concentrations of 0.5, 1 and 4ug/ml to the Vitek 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek 2 and is indicated for use in Vitek 2 Gram Positive Susceptibility Cards for the susceptibility testing of gram positive organism to norfloxacin in the range of =16ug/ml.