PMA P060007S026

Device: ARCHITECT HBSAG/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S026
Product code: LOM
Decision date: 2013-03-13
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.

Current openFDA PMA Record

Device: ARCHITECT HBSAG/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S026
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2013-03-13
Decision code: OK30
Date received: 2013-02-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.