Atellica IM Total PSA II (tPSAII) — Siemens Healthcare Diagnostics, Inc. (510(k) K251630)
Atellica IM Total PSA II (tPSAII) — Siemens Healthcare Diagnostics, Inc. (510(k) K251630) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Atellica IM Total PSA II (tPSAII); Applicant: Siemens Healthcare Diagnostics, Inc.; Clearance track: 510(k).
| Device name | Atellica IM Total PSA II (tPSAII) |
|---|---|
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Clearance track | 510(k) |
| Submission number | K251630 |
| Decision | Substantially Equivalent |
| Decision date | 2026-01-05 |
| Date received | 2025-05-28 |
| Product code | LTJ |
| Device class | 2 |
| Medical specialty | Immunology |
| Applicant location | NY, US |
| Source | openFDA device |
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