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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTD CYCLOSPORINE AND METABOLITES SERUM ASSAY
Classification Namefluroesence polorization immunoassay for cyclosporine
Generic Namecyclosporine and metabolites serum assay
Regulation Number862.1235
ApplicantABBOTT LABORATORIES
PMA NumberP890025
Date Received04/10/1989
Decision Date12/14/1989
Reclassified Date 10/16/2002
Product Code
MGU
Docket Number 89M-0523
Notice Date 01/19/1990
Advisory Committee Toxicology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S012 S013 S014 
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