PMA P110029S026
- Device
- ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S026
- Product code
- LOM
- Decision date
- 2017-09-27
- 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 in conditions for specimen centrifugation.
Current openFDA PMA Record#
- Device
- ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S026
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-09-27
- Decision code
- APPR
- Date received
- 2017-06-30
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes in conditions for specimen centrifugation.