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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBIO-RAD CYCLOSPORINE BY HPLC TEST
Classification Namehigh performance liquid chromatography for cyclosporine
Generic Namehigh performance liquid chromatography cyclosporine
Regulation Number862.1235
ApplicantBIO-RAD
PMA NumberP880032
Date Received04/21/1988
Decision Date07/24/1989
Reclassified Date 10/16/2002
Product Code
MGS
Docket Number 89M-0321
Notice Date 08/22/1989
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
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