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LTJ

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Product code
LTJ
Device name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Device class
Class 2
21 CFR
21 CFR 866.6010
Medical specialty
Immunology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
34 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-01-05.

NumberDecision dateApplicantDevice nameSummary
K2516302026-01-05Siemens Healthcare Diagnostics, Inc.Atellica IM Total PSA II (tPSAII)PDF

1 summaries are archived here for direct download.

Official FDA classification page: LTJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).