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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.
 
DeviceAPI 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantANALYTICAL PRODUCTS, INC.
200 EXPRESS STREET
PLAINVIEW, NY 11803-
PMA NumberP800029
Date Received06/02/1980
Decision Date01/30/1981
Reclassified Date 05/06/2003
Product Code LON 
Notice Date 04/28/1981
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Supplements: S001 S002 S003 S005 S007 S008 S009 S010  
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