PMA P060005S014
- Device
- IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S014
- Decision date
- 2022-03-29
- Approval order statement
- Implementation of a change to the physical state of a raw material.
Current openFDA PMA Record#
- Device
- IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S014
- Decision date
- 2022-03-29
- Decision code
- OK30
- Date received
- 2022-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a change to the physical state of a raw material.