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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameIMX TACROLIMUS II
Classification Nameenzyme immunoassay, tracrolimus
Generic Nametacrolimus
Regulation Number862.1678
ApplicantABBOTT LABORATORIES
PMA NumberP970007
Supplement NumberS003
Date Received07/30/2001
Decision Date09/05/2002
Product Code
MLM[ Registered Establishments with MLM ]
Advisory Committee Toxicology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the abbott imx tacrolimus ii master lot testing.
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