510(k) K251630 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Atellica IM Total PSA II (tPSAII)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 5, 2026 |
| Received | May 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251630
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.