K251630

Substantially Equivalent

Atellica IM Total PSA II (tPSAII)

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: LTJ
Advisory panel: Immunology
Date received: 2025-05-28
Decision date: 2026-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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