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: QUANTITOPE 125I AFP KIT AND CONTROL SERUM
• Generic Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Applicant: Bio-Rad Laboratories, Inc.; 3 Blvd. Raymond Poincare'; Marnes-La-Coquette 92430
• PMA Number: P800025
• Supplement Number: S003
• Date Received: 04/01/1985
• Decision Date: 07/17/1985
• Withdrawal Date: 04/03/2009
• Product Code: LOK
• Advisory Committee: Immunology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No