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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAPI 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility system
Regulation Number866.1645
ApplicantANALYTICAL PRODUCTS, INC.
PMA NumberP800029
Date Received06/02/1980
Decision Date01/30/1981
Reclassified Date 05/06/2003
Product Code
LON[ Registered Establishments with LON ]
Notice Date 04/28/1981
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 S007 S008 S009 S010 
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