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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.
Classification Namefluroesence polorization immunoassay for cyclosporine
Generic Namefluroesence polorization immunoassay for cyclosporine
Regulation Number862.1235
ApplicantAbbott Laboratories
PMA NumberP890025
Supplement NumberS010
Date Received03/03/1997
Decision Date02/13/1998
Product Code
Advisory Committee Toxicology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change in monoclonal antibody manufacturing site from sandoz pharmaceuticals ag. , switzerland to abbott laboratories, abbott park, il usa, under the trade name tdx(r)/tdxflx(r) cyclosporine monoclonal whole blood assay, it is indicated for the quantitative measurement of cyclosporine as an aid in the management of cardiac, liver, and renal transplant patients.