PMA P060009S001

Device: AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS
Applicant: Abbott Laboratories, Inc.
PMA number: P060009
Supplement: S001
Product code: LOM
Decision date: 2007-02-05
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.

Current openFDA PMA Record#

Device: AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS
Applicant: Abbott Laboratories, Inc.
PMA number: P060009
Supplement: S001
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2007-02-05
Decision code: OK30
Date received: 2007-01-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.