PMA P060007S020

Device: ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S020
Product code: LOM
Decision date: 2012-09-14
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGE TO A TEST METHOD USED IN THE MANUFACTURE OF THE COMPONENTS OF THEARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAY, AND THE ARCHITECT HBSAG

Current openFDA PMA Record

Device: ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S020
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2012-09-14
Decision code: OK30
Date received: 2012-08-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO A TEST METHOD USED IN THE MANUFACTURE OF THE COMPONENTS OF THEARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAY, AND THE ARCHITECT HBSAG