ADVIA Centaur Anti-Thyroid Peroxidase II

FDA 510(k) Premarket Notification · Submission K250250 · Applicant: Siemens Healthcare Diagnostics, Inc.

Public Record 510(k) Submission Decision Date: 2025-10-17 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K250250.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K250250
Device Name
ADVIA Centaur Anti-Thyroid Peroxidase II
Product Code
JZO
Decision Date
2025-10-17
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Immunology (IM)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2025-01-28

Related Establishments / Registrations

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