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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"
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
PMA NumberN50510
Supplement NumberS083
Date Received07/09/1998
Decision Date09/15/1998
Product Code
LTW[ Registered Establishments with LTW ]
Docket Number N
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the removal of a limitation for the testing of pseudomonas aeruginosa with the antibiotic cefepime.
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