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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.
 
DeviceANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Dept 9va Ap6c-2
Abbott Park, IL 60064
PMA NumberN50525
Supplement NumberS023
Date Received06/13/1989
Decision Date11/16/1989
Withdrawal Date12/10/2007
Product Code LON 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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