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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(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID
Generic NameSusceptibility test cards, antimicrobial
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS128
Date Received03/09/2000
Decision Date04/17/2000
Reclassified Date12/28/2001
Product Codes LTW LON 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the antibiotic ticarcillin/clavulanic acid at concentrations of 8/2, 32/2, 64/2 ug/ml ot the Vitek 2 Gram Negative Susceptibility Test System.
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