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-ROCHE(R) EIA
• Generic Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Regulation Number: 866.6010
• Applicant: Roche Diagnostics GmbH; 1080 U.S. Hwy. 202; Branchburg Township; Somerville, NJ 08876
• PMA Number: P840027
• Supplement Number: S006
• Date Received: 04/11/1989
• Decision Date: 05/01/1989
• Withdrawal Date: 09/27/2007
• Product Code: DHX
• Advisory Committee: Immunology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No