Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: AMERSHAM AFP
• Generic Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Applicant: Ortho Clinical Diagnostics; 100 Indigo Creek Dr.; Rochester, NY 14626-5101
• PMA Number: P780006
• Date Received: 10/12/1978
• Decision Date: 06/07/1984
• Withdrawal Date: 07/31/2018
• Product Code: LOK
• Docket Number: 84M-0227
• Notice Date: 07/06/1984
• Advisory Committee: Immunology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Supplements: S002 S003