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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.
 
DeviceTDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD
Classification Namefluroesence polorization immunoassay for cyclosporine
Generic Namefluroesence polorization immunoassay for cyclosporine
Regulation Number862.1235
Applicant
Abbott Laboratories
abbott labs
abbott park, IL 60064
PMA NumberP890025
Supplement NumberS013
Date Received06/25/2001
Decision Date09/05/2002
Product Code
MGU
Advisory Committee Toxicology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to place into effect the updated quality control test for evaluating sheep antiserum.
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