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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 (ESBL)
Generic NameSusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS081
Date Received04/22/1998
Decision Date08/14/1998
Reclassified Date12/28/2001
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the testing of Escherichia coli, Klebsiella pneumoniae, and K. oxytoca for the presence of extended-spectrum beta lactamases (ESBL).
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