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FDA 510(k)

ADVIA Centaur Anti-Thyroid Peroxidase II

K-Number: K250250 · 2025-10-17

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2025-10-17
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Anti-Thyroid Peroxidase II is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K250250. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Anti-Thyroid Peroxidase II?

ADVIA Centaur Anti-Thyroid Peroxidase II is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K250250.

When did ADVIA Centaur Anti-Thyroid Peroxidase II receive FDA 510(k) clearance?

ADVIA Centaur Anti-Thyroid Peroxidase II received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250250.

Who is the listed applicant for ADVIA Centaur Anti-Thyroid Peroxidase II?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Anti-Thyroid Peroxidase II?

The FDA product code for ADVIA Centaur Anti-Thyroid Peroxidase II is JZO.

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Related Devices (Code: JZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia ABK152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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