PMA P010051S013
- Device
- IMMULITE 2000 Anti-HBc
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010051
- Supplement
- S013
- Product code
- LOM
- Decision date
- 2020-09-08
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Remove select inspection criteria from the raw materials used to manufacture IMMULITE Substrate Reagent.
Current openFDA PMA Record#
- Device
- IMMULITE 2000 Anti-HBc
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010051
- Supplement
- S013
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2020-09-08
- Decision code
- OK30
- Date received
- 2020-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove select inspection criteria from the raw materials used to manufacture IMMULITE Substrate Reagent.