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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 IMIPENEM
Generic NameSusceptibility test cards, antimicrobial
ApplicantBIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD, MO 63042-2395
PMA NumberN50510
Supplement NumberS129
Date Received03/09/2000
Decision Date04/26/2000
Reclassified Date 12/28/2001
Product Codes LON LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The device, as modified, will be marketed under the trade name Vitek 2 Gram Negative Susceptibility Test Cards. Approval for the addition of the antibiotic imipenem at concentrations of 2, 4 and 16 micrograms/ml to the Vitek 2 Gram Negative Susceptibility Test System.
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