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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.
 
DeviceAMMENDMENT TO E. COLI ASC
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
Applicant
BIOMERIEUX VITEK, INC.
595 anglum dr.
hazelwood, MO 63042-2395
PMA NumberN50510
Supplement NumberS020
Date Received08/30/1985
Decision Date12/20/1985
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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