- Device
- Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S013
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-03-29
- Decision code
- OK30
- Date received
- 2022-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture an instrument component at another location.