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: ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)
• Generic Name: HEPATITIS DELTA SEROLOGICAL REAGENTS
• Applicant: Abbott Laboratories; 100 Abbott Park Rd.; Abbott Park, IL 60064
• PMA Number: P850062
• Supplement Number: S001
• Date Received: 08/30/1985
• Decision Date: 07/29/1986
• Withdrawal Date: 03/22/2007
• Product Code: LQI
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No