PMA P060007S004
- Device
- ABBOTT ARCHITECT HBSAG AND ARCHITECT HBSAG CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P060007
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2011-04-04
- Generic name
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
Current openFDA PMA Record
- Device
- ABBOTT ARCHITECT HBSAG AND ARCHITECT HBSAG CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P060007
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-04-04
- Decision code
- APPR
- Date received
- 2010-10-01
- 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 IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.