PMA P060007S015

Device: ARCHITECT HBSAG/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S015
Product code: LOM
Decision date: 2011-06-24
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS.

Current openFDA PMA Record

Device: ARCHITECT HBSAG/CONFIRMATORY
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S015
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-06-24
Decision code: OK30
Date received: 2011-05-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS.