PMA P060012S003

Device: AXSYM CORE 2.0
Applicant: Abbott Laboratories, Inc.
PMA number: P060012
Supplement: S003
Product code: LOM
Decision date: 2010-10-20
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGE TO THE MANUFACTURING PROCESS AND QUALITY CONTROL TEST METHOD FOR THE HBCAG SOLUTIO NAND THE CHANGE TO THE MANUFACTURING PROCESS FOR THE QUALIFIED RHBCAG USED IN THE AXSYM CORE 2.0 ASSAY.

Current openFDA PMA Record#

Device: AXSYM CORE 2.0
Applicant: Abbott Laboratories, Inc.
PMA number: P060012
Supplement: S003
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2010-10-20
Decision code: OK30
Date received: 2010-09-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE MANUFACTURING PROCESS AND QUALITY CONTROL TEST METHOD FOR THE HBCAG SOLUTIO NAND THE CHANGE TO THE MANUFACTURING PROCESS FOR THE QUALIFIED RHBCAG USED IN THE AXSYM CORE 2.0 ASSAY.