IMMULITE® 2000 Prostate-Specific Antigen (PSA)
FDA premarket approval P930027/S035 · decided 2025-02-21
Approval details
- PMA number
- P930027
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE® 2000 Prostate-Specific Antigen (PSA)
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2025-01-31
- Decision date
- 2025-02-21
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Approval for the move of critical raw material operations of an internal supplier in-house to an internal company site
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| Atellica IM Total PSA II (tPSAII) (K251630) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 |
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