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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAMMENDMENT TO E. COLI ASC
Generic NameSusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD, MO 63042-2395
PMA NumberN50510
Supplement NumberS012
Date Received08/13/1984
Decision Date02/19/1985
Reclassified Date 12/28/2001
Product Code LTW 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
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