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: AFP RIA KIT
• Generic Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Applicant: Alere, Inc.; 10 Southgate Rd.; Scarborough, ME 04074
• PMA Number: P760001
• Supplement Number: S001
• Date Received: 06/22/1982
• Decision Date: 03/01/1984
• Withdrawal Date: 07/20/2011
• Product Code: LOK
• Advisory Committee: Immunology
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No