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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVITEK SYSTEMS "GENERAL SUSCEPTIBILITY CARD" (ESBL)
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
PMA NumberN50510
Supplement NumberS081
Date Received04/22/1998
Decision Date08/14/1998
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
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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