PMA P110029S001

Device: ARCHITECT I1000 SYSTEM
Applicant: Abbott Laboratories
PMA number: P110029
Supplement: S001
Product code: LOM
Decision date: 2013-01-10
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR THE MIGRATION OF THE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAYS TO THE ARCHITECT I LOOOSR ANALYZER.

Current openFDA PMA Record#

Device: ARCHITECT I1000 SYSTEM
Applicant: Abbott Laboratories
PMA number: P110029
Supplement: S001
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2013-01-10
Decision code: APPR
Date received: 2012-05-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MIGRATION OF THE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAYS TO THE ARCHITECT I LOOOSR ANALYZER.