PMA N50510S135

Device: VITEK 2 GRAM POSITIVE AST FOR CEFTRIAXONE
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S135
Product code: LTW
Decision date: 2000-06-21
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CEFTRIAXONE AT CONCENTRATIONS OF 0.06, 0.25, 0.5, AND 1 MICROGRAM/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO CEFTRIAXONE IN THE RANGE OF ,+0.06 TO >=4 MICROGRAMS/ML.

Current openFDA PMA Record#

Device: VITEK 2 GRAM POSITIVE AST FOR CEFTRIAXONE
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S135
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-06-21
Decision code: APPR
Date received: 2000-04-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CEFTRIAXONE AT CONCENTRATIONS OF 0.06, 0.25, 0.5, AND 1 MICROGRAM/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO CEFTRIAXONE IN THE RANGE OF ,+0.06 TO >=4 MICROGRAMS/ML.