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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceIMX TACROLIMUS II
Generic NameENZYME IMMUNOASSAY, TRACROLIMUS
Regulation Number862.1678
ApplicantAbbott Laboratories
200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064
PMA NumberP970007
Supplement NumberS004
Date Received07/30/2001
Decision Date09/05/2002
Reclassified Date 10/16/2002
Product Code MLM 
Advisory Committee Toxicology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ADDITION OF TESTING OF MODEL 1 CALIBRATOR TO VERIFY THE PROPER FILLING OF THE CALIBRATOR.
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