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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 NameTDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
Classification Namefluroesence polorization immunoassay for cyclosporine
Generic Namecyclosporine and metabolites whole blood assay
Regulation Number862.1235
ApplicantABBOTT LABORATORIES
PMA NumberP890025
Supplement NumberS005
Date Received10/28/1992
Decision Date12/17/1992
Product Code
MGU
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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