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: ABBOTT CEA-EIA KIT
• Generic Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Regulation Number: 866.6010
• Applicant: Abbott Laboratories; Dept: 09v8 Bldg: Ap5-2; 100 Abbott Park Rd.; Abbott Park, IL 60064
• PMA Number: P830066
• Supplement Number: S002
• Date Received: 03/05/1986
• Decision Date: 07/07/1986
• Product Code: DHX
• Advisory Committee: Immunology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No