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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Nameenzyme immunoassay, tracrolimus
Generic Nameenzyme immunoassay, tracrolimus
Regulation Number862.1678
1990 industrial blvd.
p.o. box 285
stillwater, MN 55082
PMA NumberP970025
Date Received06/30/1997
Decision Date04/27/1999
Reclassified Date 09/16/2002
Product Code
MLM[ Registered Establishments with MLM ]
Docket Number 01M-0072
Notice Date 02/16/2001
Advisory Committee Toxicology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for PRO-Trac(TM) II Tacrolimus ELISA Kit. This device is indicated for the quantitative determination of tacrolimus ELISA Kit. This device indicated for the quantitative determination of tacrolimus (Prograf(R) FK506) and some metabolites in EDTA or heparinized human whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling