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: AMERSHAM AFP
• Generic Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Applicant: Ortho Clinical Diagnostics; 100 Indigo Creek Dr.; Rochester, NY 14626
• PMA Number: P780006
• Supplement Number: S002
• Date Received: 10/31/1985
• Decision Date: 03/17/1986
• Withdrawal Date: 07/31/2018
• Product Code: LOK
• Advisory Committee: Immunology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No