PMA P080023S003
- Device
- ARCHITECT CORE
- Applicant
- Abbott Laboratories
- PMA number
- P080023
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2011-07-20
- 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 A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD. IN SINGAPORE.
Current openFDA PMA Record#
- Device
- ARCHITECT CORE
- Applicant
- Abbott Laboratories
- PMA number
- P080023
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-07-20
- 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 FLEXTRONICS MANUFACTURING (S) PTE. LTD. IN SINGAPORE.