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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 NameAMMENDMENT TO E. COLI ASC
Classification Namesusceptibility test cards, antimicrobial
Generic Nameproteus antimicrobial susceptibility card
Regulation Number866.1640
ApplicantVITEK SYSTEMS, INC.
PMA NumberN50510
Supplement NumberS014
Date Received11/01/1984
Decision Date02/19/1985
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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