PMA P050051S005

Device: ARCHITECT AUSAB
Applicant: Abbott Laboratories, Inc.
PMA number: P050051
Supplement: S005
Product code: LOM
Decision date: 2011-04-04
Classification: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND AND A MANUFACTURING SITE AT ABBOTT DIAGNOSTICS DIVISION, MUREX BIOTECH LIMITED IN KENT, UNITED KINGDOM.

Current openFDA PMA Record#

Device: ARCHITECT AUSAB
Applicant: Abbott Laboratories, Inc.
PMA number: P050051
Supplement: S005
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-04-04
Decision code: APPR
Date received: 2010-08-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND AND A MANUFACTURING SITE AT ABBOTT DIAGNOSTICS DIVISION, MUREX BIOTECH LIMITED IN KENT, UNITED KINGDOM.