K251630
- 510(k) number
- K251630
- Device name
- Atellica IM Total PSA II (tPSAII)
- Applicant
- Siemens Healthcare Diagnostics, Inc. NY · US
- Product code
- LTJ — Prostate-Specific Antigen (Psa) For Management Of Pr
- Decision date
- 2026-01-05
- Date received
- 2025-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251630.pdf
Official FDA record: K251630
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.