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Device | PRO-TRAC II TACROLIMUS ELISA KIT |
Generic Name | ENZYME IMMUNOASSAY, TRACROLIMUS |
Regulation Number | 862.1678 |
Applicant | DIASORIN, INC. 1990 INDUSTRIAL BLVD. P.O. BOX 285 STILLWATER, MN 55082 |
PMA Number | P970025 |
Date Received | 06/30/1997 |
Decision Date | 04/27/1999 |
Reclassified Date
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09/16/2002 |
Product Code |
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
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Supplements: |
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