PMA P050051S002
- Device
- ABBOTT ARCHITECT
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S002
- Product code
- LOM
- Decision date
- 2007-12-05
- 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 CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN AND CHANGE OF GRAYZONE RANGE.
Current openFDA PMA Record#
- Device
- ABBOTT ARCHITECT
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S002
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2007-12-05
- Decision code
- APPR
- Date received
- 2007-10-19
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN AND CHANGE OF GRAYZONE RANGE.