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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 NEGATIVE AST FOR LEVOFLOXACIN
Generic NameSusceptibility test cards, antimicrobial
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS098
Date Received07/28/1999
Decision Date11/05/1999
Reclassified Date12/28/2001
Product Codes LON LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the antibiotic levofloxacin at concentrations of 0.5, and 8ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System. The device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to levofloxacin in the range of <0.25 to >8ug/ml.
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