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): 34

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

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

Number	Decision date	Applicant	Device name
K251630	2026-01-05	Siemens Healthcare Diagnostics, Inc.	Atellica IM Total PSA II (tPSAII) summary

Official FDA classification page: LTJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).