Atellica IM Prostate-Specific Antigen (PSA)
FDA premarket approval P950021/S029 · decided 2024-09-23
Approval details
- PMA number
- P950021
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica 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
- 2024-06-25
- Decision date
- 2024-09-23
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- placement of Atellica IM assay onto the Atellica CI Analyzer with Atellica Sample Handler configuration.
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