- Device
- IMMULITE® 2000 Anti-HBc IgM
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010053
- Supplement
- S016
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-10-14
- Decision code
- OK30
- Date received
- 2022-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in material composition of the glass bulb used in PMT (Photo Multiplier Tube) Assembly on the IMMULITE Family of Instruments.