PMA P060007S003

Device: ABBOTT ARCHITECT HBSAG
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S003
Product code: LOM
Decision date: 2009-06-05
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR IMPLEMENTATION OF A NEW QUALITY CONTROL TESTING PROCEDURE WITH A 100-MEMBER PANEL FOR THE ARCHITECT HBSAG REAGENT CONJUGATE.

Current openFDA PMA Record

Device: ABBOTT ARCHITECT HBSAG
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S003
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2009-06-05
Decision code: APPR
Date received: 2009-06-03
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR IMPLEMENTATION OF A NEW QUALITY CONTROL TESTING PROCEDURE WITH A 100-MEMBER PANEL FOR THE ARCHITECT HBSAG REAGENT CONJUGATE.