PMA P050049S003
- Device
- AXSYM HBSAG, AXSYM HBSAG CONFIRMATORY AND AXSYM HBSAG CONTROLS
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2008-12-17
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR CHANGE OF ASSAY FILES THAT MONITOR LIQUID LEVELS.
Current openFDA PMA Record#
- Device
- AXSYM HBSAG, AXSYM HBSAG CONFIRMATORY AND AXSYM HBSAG CONTROLS
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2008-12-17
- Decision code
- APPR
- Date received
- 2008-10-24
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR CHANGE OF ASSAY FILES THAT MONITOR LIQUID LEVELS.