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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 NameIMX TACROLIMUS II ASSAY
Generic Nametacrolimus
ApplicantABBOTT LABORATORIES
PMA NumberP970007
Date Received02/18/1997
Decision Date08/26/1997
Reclassified Date 10/16/2002
Docket Number 97M-0520
Notice Date 01/06/1998
Advisory Committee Toxicology
Expedited Review Granted? Yes
Combination Product No
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 
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