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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFLOW MIC SYSTEM
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Namesystem, test, automated, antimicrobial susceptibility, short incubation
Regulation Number866.1645
Applicant
FLOW LABORATORIES, INC.
7655 old springhouse rd.
mclean, VA 22102
PMA NumberN50538
Date Received09/14/1979
Decision Date07/15/1980
Reclassified Date 05/06/2003
Product Code
LON[ Registered Establishments with LON ]
Notice Date 11/20/1980
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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