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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.
 
DeviceTDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
Generic NameFluorescence polarization immunoassay for cyclosporine
Regulation Number862.1235
ApplicantAbbott Laboratories
ABBOTT LABS
ABBOTT PARK, IL 60064
PMA NumberP890025
Supplement NumberS003
Date Received09/09/1991
Decision Date03/18/1992
Reclassified Date 10/16/2002
Product Code MGU 
Advisory Committee Toxicology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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