PMA P050051S003
- Device
- ABBOTT ARCHITECT AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2008-11-13
- 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 CHANGE OF GRAYZONE RANGE AND CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN.
Current openFDA PMA Record#
- Device
- ABBOTT ARCHITECT AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2008-11-13
- Decision code
- APPR
- Date received
- 2008-09-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGE OF GRAYZONE RANGE AND CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN.