PMA N50510S106

Device: VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S106
Product code: LTW
Decision date: 2000-01-10
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: Approval for the addition of the antibiotic levofloxacin at concentrations of 0.25, 2 and 8ug/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 Test Cards for the susceptibility testing of gram positive organism to levofloxacin in the range of <=.125 to >= 8ug/ml.

Current openFDA PMA Record#

Device: VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S106
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-01-10
Decision code: APPR
Date received: 1999-08-20
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of the antibiotic levofloxacin at concentrations of 0.25, 2 and 8ug/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 Test Cards for the susceptibility testing of gram positive organism to levofloxacin in the range of = 8ug/ml.