Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: ABBOTT AXSYM AUSAB
• Classification Name: test, hepatitis b (b core, be antigen, be antibody, b core igm)
• Applicant: ABBOTT LABORATORIES INC
• PMA Number: P060003
• Supplement Number: S010
• Date Received: 09/06/2011
• Decision Date: 10/03/2011
• Product Code: LOM [ Registered Establishments with LOM ]
• Advisory Committee: Microbiology
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change to vendor for the incoming non-fat dry milk.