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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 GENTAMICIN
Generic NameSusceptibility test cards, antimicrobial
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS104
Date Received08/20/1999
Decision Date01/06/2000
Reclassified Date12/28/2001
Product Codes LTW LON 
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 gentamicin at concentrations of 4, 16, and 32 ug/ml to the Viteck 2 Gram Negative 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 Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to gentamicin in the range of <=1 to >=16 ug/ml.
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