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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/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD
Generic NameFluorescence polarization immunoassay for cyclosporine
Regulation Number862.1235
ApplicantAbbott Laboratories
Abbott Labs
Abbott Park, IL 60064
PMA NumberP890025
Supplement NumberS014
Date Received03/18/2002
Decision Date09/05/2002
Reclassified Date10/16/2002
Product Code MGU 
Advisory Committee Toxicology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
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