PMA P060003S005
- Device
- ABBOTT AXSYM AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060003
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2011-06-09
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR CHANGES TO THE MANUFACTURING AND QUALITY CONTROL TESTING FOR AXSYM AUSAB CALIBRATORS, CONTROLS, AND REAGENTS.
Current openFDA PMA Record#
- Device
- ABBOTT AXSYM AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060003
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-06-09
- Decision code
- APPR
- Date received
- 2010-06-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE MANUFACTURING AND QUALITY CONTROL TESTING FOR AXSYM AUSAB CALIBRATORS, CONTROLS, AND REAGENTS.