PMA P050051S001

Device: ARCHITECT AUSAB REAGENT KIT, ARCHITECT AUSAB CALIBRATORS, ARCHITECT AUSAB CONTROLS
Applicant: Abbott Laboratories, Inc.
PMA number: P050051
Supplement: S001
Product code: LOM
Decision date: 2006-08-07
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 THE ADDITION OF A TEST METHOD TO DETECT CHANGES BETWEEN THE BULK AND THE MASTER LOT (CUSTOMER RELEASE) TESTING STAGES.

Current openFDA PMA Record#

Device: ARCHITECT AUSAB REAGENT KIT, ARCHITECT AUSAB CALIBRATORS, ARCHITECT AUSAB CONTROLS
Applicant: Abbott Laboratories, Inc.
PMA number: P050051
Supplement: S001
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2006-08-07
Decision code: APPR
Date received: 2006-06-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF A TEST METHOD TO DETECT CHANGES BETWEEN THE BULK AND THE MASTER LOT (CUSTOMER RELEASE) TESTING STAGES.