PMA P060007S002

Device: ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S002
Product code: LOM
Decision date: 2009-07-13
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT HBSAG/ ARCHITECT HBSAG CONFIRMATORY ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/I2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.

Current openFDA PMA Record

Device: ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM
Applicant: Abbott Laboratories
PMA number: P060007
Supplement: S002
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2009-07-13
Decision code: APPR
Date received: 2009-01-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT HBSAG/ ARCHITECT HBSAG CONFIRMATORY ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/I2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.