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: ENCORE AFP
• Generic Name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
• Regulation Number: 866.6010
• Applicant: Beckman Coulter, Inc.; 7330 Carroll Rd.; P.O. Box 269006; San Diego, CA 92196
• PMA Number: P840035
• Supplement Number: S002
• Date Received: 01/22/1986
• Decision Date: 04/08/1986
• Product Code: LOJ
• Advisory Committee: Immunology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No