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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.
Classification Nameenzyme immunoassay, tracrolimus
Generic Nametacrolimus
Regulation Number862.1678
PMA NumberP970007
Date Received02/18/1997
Decision Date08/26/1997
Reclassified Date 10/16/2002
Product Code
MLM[ Registered Establishments with MLM ]
Docket Number 97M-0520
Notice Date 01/06/1998
Advisory Committee Toxicology
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the imx(r) tacrolimus ii assay. This device is indicated for use as an in-vitro reagent sytemf or the quantitative determination of tacrolimus and some metabolites in human whole blood as an aid in the management of liver allograft patients receiving tacrolimus therapy.
Supplements: S001 S002 S003 S004