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: TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
• Generic Name: Fluorescence polarization immunoassay for cyclosporine
• Regulation Number: 862.1235
• Applicant: Abbott Laboratories; Abbott Labs; Abbott Park, IL 60064
• PMA Number: P890025
• Supplement Number: S008
• Date Received: 08/26/1993
• Decision Date: 03/31/1994
• Reclassified Date: 10/16/2002
• Product Code: MGU
• Advisory Committee: Toxicology
• 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