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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 NumberS009
Date Received01/16/1996
Decision Date04/01/1996
Reclassified Date10/16/2002
Product Code MGU 
Advisory Committee Toxicology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
NEW PROBE CLEANING PROCEDURE
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