PMA P060003S004

Device: ABBOTT AXSYM AUSAB
Applicant: Abbott Laboratories, Inc.
PMA number: P060003
Supplement: S004
Product code: LOM
Decision date: 2009-03-05
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: ADDITION OF A NEW QUALITY CONTROL TESTING PROCEDURE TO EVALUATE THE SUITABILITY OF RECALCIFIED NONREACTIVE PLASMA USED IN ANTI-HBS POSITIVE COMPONENTS.

Current openFDA PMA Record#

Device: ABBOTT AXSYM AUSAB
Applicant: Abbott Laboratories, Inc.
PMA number: P060003
Supplement: S004
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2009-03-05
Decision code: OK30
Date received: 2009-02-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW QUALITY CONTROL TESTING PROCEDURE TO EVALUATE THE SUITABILITY OF RECALCIFIED NONREACTIVE PLASMA USED IN ANTI-HBS POSITIVE COMPONENTS.