Atelica IM Prostate-Specific Antigen (PSA)
FDA premarket approval P950021/S026 · decided 2024-05-15
Approval details
- PMA number
- P950021
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atelica IM Prostate-Specific Antigen (PSA)
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2023-11-20
- Decision date
- 2024-05-15
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- migration of the ADVIA Centaur PSA assay to the Atellica CI Analyzer
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