Premarket Approval (PMA)

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.

• Device: BIO-RAD CYCLOSPORINE BY HPLC TEST
• Generic Name: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE
• Regulation Number: 862.1235
• Applicant: Bio-Rad; 4000 Alfred Nobel Dr.; Hercules, CA 94547
• PMA Number: P880032
• Supplement Number: S001
• Date Received: 12/06/1990
• Decision Date: 03/14/1991
• Reclassified Date: 10/16/2002
• Product Code: MGS
• Advisory Committee: Clinical Chemistry
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No