ADVIA Centaur Anti-Thyroid Peroxidase II— 510(k) K250250

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K250250 for ADVIA Centaur Anti-Thyroid Peroxidase II, Substantially Equivalent on 2025-10-17. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JZO
Advisory panel: Immunology
Date received: 2025-01-28
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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