IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA
FDA premarket approval P060005/S014 · decided 2022-03-29
Approval details
- PMA number
- P060005
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- Date received
- 2022-02-28
- Decision date
- 2022-03-29
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55
- Statement
- Implementation of a change to the physical state of a raw material.
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