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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD
Classification Namefluroesence polorization immunoassay for cyclosporine
Generic Namecyclosporine and metabolites whole blood assay
Regulation Number862.1235
ApplicantABBOTT LABORATORIES
PMA NumberP890025
Supplement NumberS014
Date Received03/18/2002
Decision Date09/05/2002
Product Code
MGU
Advisory Committee Toxicology
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add a quality control test which will be performed after the reagent pack is packaged.
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