PMA P010050S019
- Device
- IMMULITE 2000 HBs Ag Confirmatory
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010050
- Supplement
- S019
- Product code
- LOM
- Decision date
- 2021-06-09
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Update the expiry of a raw material.
Current openFDA PMA Record#
- Device
- IMMULITE 2000 HBs Ag Confirmatory
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010050
- Supplement
- S019
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-06-09
- Decision code
- OK30
- Date received
- 2021-05-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the expiry of a raw material.