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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN
Generic NameSusceptibility test cards, antimicrobial
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS141
Date Received11/16/2000
Decision Date05/14/2001
Reclassified Date12/28/2001
Product Codes LON LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC SPARFLOXACIN AT CONCENTRATIONS OF 0.5, 1.0, AND 8.0 MCG/ML TO THE VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK. 2 GRAM POSITIVE AST FOR SPARFLOXACIN AND IS INDICATED FOR USE IN VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO SPARFLOXACIN IN THE RANGE OF <= 0.25 TO >= 8 MCG/ML.
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