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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAUTOBAC MIC TEST SYSTEM
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM, NC 27712
PMA NumberN50524
Supplement NumberS029
Date Received08/09/1988
Decision Date09/26/1988
Reclassified Date 05/06/2003
Product Code LON 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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