Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | IMX TACROLIMUS II ASSAY |
Generic Name | ENZYME IMMUNOASSAY, TRACROLIMUS |
Regulation Number | 862.1678 |
Applicant | Abbott Laboratories 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 |
PMA Number | P970007 |
Date Received | 02/18/1997 |
Decision Date | 08/26/1997 |
Reclassified Date
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10/16/2002 |
Product Code |
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 |
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