PMA P030056S020
- Device
- Atellica IM Hepatitis C (aHCV) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030056
- Supplement
- S020
- Product code
- MZO
- Decision date
- 2021-04-27
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Moving manufacturing of Atellica IM analyzers component/subassembly named Autoloader to an internal supplier.
Current openFDA PMA Record#
- Device
- Atellica IM Hepatitis C (aHCV) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030056
- Supplement
- S020
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2021-04-27
- Decision code
- OK30
- Date received
- 2021-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving manufacturing of Atellica IM analyzers component/subassembly named Autoloader to an internal supplier.