PMA P060012S002

Device: AXSYM CORE 2.0
Applicant: Abbott Laboratories, Inc.
PMA number: P060012
Supplement: S002
Product code: LOM
Decision date: 2010-06-03
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: CHANGE TO THE MATCHING TEST PROCEDURE TO ALLOW OPTIMIZATION OF MICROPARTICLE PERCENT SOLIDS BASED ON A TARGET INDEX CALIBRATOR SIGNAL RATE COUNT.

Current openFDA PMA Record#

Device: AXSYM CORE 2.0
Applicant: Abbott Laboratories, Inc.
PMA number: P060012
Supplement: S002
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2010-06-03
Decision code: OK30
Date received: 2010-05-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE MATCHING TEST PROCEDURE TO ALLOW OPTIMIZATION OF MICROPARTICLE PERCENT SOLIDS BASED ON A TARGET INDEX CALIBRATOR SIGNAL RATE COUNT.