PMA P110041S006
- Device
- Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S006
- Product code
- LOM
- Decision date
- 2018-09-11
- 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 the placement of these assays on the Atellica Solution.
Current openFDA PMA Record#
- Device
- Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S006
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2018-09-11
- Decision code
- APPR
- Date received
- 2018-07-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the placement of these assays on the Atellica Solution.