IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA)
FDA premarket approval P060005/S022 · decided 2025-08-14
Approval details
- PMA number
- P060005
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA)
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- Date received
- 2025-07-18
- Decision date
- 2025-08-14
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55
- Statement
- Approval for the move of critical raw material operations of an internal supplier in-house to an internal company
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