IMMULITE 2000 PSA
FDA premarket approval P930027/S039 · decided 2026-07-27
Approval details
- PMA number
- P930027
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE 2000 PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2026-06-29
- Decision date
- 2026-07-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Approval of the change to in-process manufacturing quality testing for the IMMULITE 2000 XPi analyzers and IMMULITE 2000 / IMMULITE 2000 XPi spare probe assemblies.
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