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: CEA--RIA DIXGNOSTIC TEST KIT
• Generic Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Regulation Number: 866.6010
• Applicant: Abbott Laboratories; Abbott Park, IL 60064
• PMA Number: P800056
• Supplement Number: S001
• Date Received: 12/31/1980
• Decision Date: 03/11/1981
• Product Code: DHX
• Advisory Committee: Immunology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No