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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 SYSTEMS GENERAL SUSCEPTIBILITY CARD
Generic NameSusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD, MO 63042-2395
PMA NumberN50510
Supplement NumberS073
Date Received12/23/1996
Decision Date02/19/1997
Reclassified Date 12/28/2001
Product Code LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CEFPODOXIME TO BE INCLUDED ON THE GRAM NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATION (EQUIVALENT TO 1, 2 AND 4 UG/ML)
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