PMA P050049S005
- Device
- AXSYM HBSAG/CONFIRMATORY
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2011-05-20
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
Current openFDA PMA Record#
- Device
- AXSYM HBSAG/CONFIRMATORY
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-05-20
- Decision code
- APPR
- Date received
- 2010-11-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.