PMA P060007S013

Device: ARCHITECT HBSAG/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S013
Product code: LOM
Decision date: 2011-05-13
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.

Current openFDA PMA Record

Device: ARCHITECT HBSAG/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S013
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-05-13
Decision code: OK30
Date received: 2011-04-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.