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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
ApplicantVITEK SYSTEMS, INC.
PMA NumberN50510
Supplement NumberS061
Date Received03/03/1994
Decision Date03/01/1995
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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