- Device
- IMMULITE 2000 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010051
- Supplement
- S023
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2025-08-04
- Decision code
- OK30
- Date received
- 2025-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an internal site to internal site transfer of a manufacturing process