PMA P050049S009

Device: AXSYM HBSAG/CONFIRMATORY (LN 9B01)
Applicant: Abbott Laboratories, Inc.
PMA number: P050049
Supplement: S009
Product code: LOM
Decision date: 2011-12-22
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.

Current openFDA PMA Record#

Device: AXSYM HBSAG/CONFIRMATORY (LN 9B01)
Applicant: Abbott Laboratories, Inc.
PMA number: P050049
Supplement: S009
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-12-22
Decision code: APPR
Date received: 2011-11-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.