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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 NameANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial suscptability test system
Regulation Number866.1645
ApplicantABBOTT LABORATORIES
PMA NumberN50525
Date Received05/05/1978
Decision Date05/04/1979
Withdrawal Date 12/10/2007
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
S025 S026 
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