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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 MEROPENEM
Generic NameSusceptibility test cards, antimicrobial
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS121
Date Received10/08/1999
Decision Date03/09/2000
Reclassified Date12/28/2001
Product Codes LON LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the antibiotic meropenem at concentrations of 0.5, 4, and 16 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.
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