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: CORAB
• Generic Name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
• Regulation Number: 866.3172
• Applicant: Abbott Laboratories; 100 Abbott Park Rd.; Dept 9va Ap6c-2; Abbott Park, IL 60064
• PMA Number: P780016
• Supplement Number: S002
• Date Received: 11/26/1979
• Decision Date: 03/17/1980
• Product Code: LOM
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No