PMA P060035S008

Device: ARCHITECT CORE-M
Applicant: Abbott Laboratories
PMA number: P060035
Supplement: S008
Product code: LOM
Decision date: 2011-06-01
Classification: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.

Current openFDA PMA Record#

Device: ARCHITECT CORE-M
Applicant: Abbott Laboratories
PMA number: P060035
Supplement: S008
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-06-01
Decision code: APPR
Date received: 2011-05-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.