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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 CYCLOSPORINE AND METABOLITES SERUME ASSAY
Classification Namefluroesence polorization immunoassay for cyclosporine
Generic Namecyclosporine and metabolites whole blood assay
Regulation Number862.1235
ApplicantABBOTT LABORATORIES
PMA NumberP890025
Supplement NumberS009
Date Received01/16/1996
Decision Date04/01/1996
Product Code
MGU
Advisory Committee Toxicology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New probe cleaning procedure.
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