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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 NumberS070
Date Received03/29/1996
Decision Date04/22/1996
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a limitation statement requiring a alternate method of testing for piperacllin in susceptibility testing of pseudomonas aeruginosa.
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