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: GAMMA DAB (125I) AFP RIA KIT
• Generic Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Applicant: Incstar Corp.; 1990 Insustrial Blvd.; P.O. Box 285; Stillwater, MN 55082
• PMA Number: P790032
• Supplement Number: S001
• Date Received: 06/10/1986
• Decision Date: 08/22/1986
• Withdrawal Date: 08/19/2002
• Product Code: LOK
• Advisory Committee: Immunology
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No