PMA P110029S004
- Device
- ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2012-09-14
- 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
- CHANGE TO A TEST METHOD USED IN THE MANUFACTURE OF THE COMPONENTS OF THEARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAY, AND THE ARCHITECT HBSAG
Current openFDA PMA Record#
- Device
- ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-09-14
- Decision code
- OK30
- Date received
- 2012-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO A TEST METHOD USED IN THE MANUFACTURE OF THE COMPONENTS OF THEARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAY, AND THE ARCHITECT HBSAG