Premarket Approval (PMA)

• Device: GONOCOCCAL PILI ANTIBODY TEST
• Generic Name: KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE
• Regulation Number: 866.2660
• Applicant: Bioquest; P.O. Box 243; Cockeysville, MD 21030
• PMA Number: P770002
• Date Received: 05/23/1977
• Decision Date: 07/18/1979
• Withdrawal Date: 12/21/2007
• Product Code: JSX
• Notice Date: 06/13/1980
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No