Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: ABBOTT HBE DIAGNOSTIC KIT
• Classification Name: test, hepatitis b (b core, be antigen, be antibody, b core igm)
• Generic Name: hbe detection kit
• Applicant: ABBOTT LABORATORIES
• PMA Number: P790025
• Date Received: 10/03/1979
• Decision Date: 07/15/1980
• Withdrawal Date: 03/22/2007
• Product Code: LOM [ Registered Establishments with LOM ]
• Docket Number: 80M-0267
• Notice Date: 09/12/1980
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S004 S006 S007 S008