PMA P060007S016

Device: ARCHITECT HBSAG/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S016
Product code: LOM
Decision date: 2011-12-21
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.

Current openFDA PMA Record

Device: ARCHITECT HBSAG/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S016
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-12-21
Decision code: APPR
Date received: 2011-11-23
Supplement type: Special (Immediate Track)
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.