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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 NameAUTOBAC MIC TEST SYSTEM
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility test system
Regulation Number866.1645
ApplicantORGANON TEKNIKA CORP.
PMA NumberN50524
Date Received04/28/1978
Decision Date05/04/1979
Reclassified Date 05/06/2003
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 S016 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S035 
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