Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-10-17 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K250250.

When was ADVIA Centaur Anti-Thyroid Peroxidase II approved by the FDA?

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

What company makes ADVIA Centaur Anti-Thyroid Peroxidase II?

ADVIA Centaur Anti-Thyroid Peroxidase II is manufactured by Siemens Healthcare Diagnostics, Inc..

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.

Other Devices by Siemens Healthcare Diagnostics, Inc.

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) K161964ADVIA Centaur HAV IgM Assay K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

View all 71 devices →

Related Devices (Code: JZO)

K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. K193313Elecsys Anti-TSHRRoche Diagnostics K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc. K222610Elecsys Anti-TgRoche Diagnostics K240469Access TPO AntibodyBeckman Coulter, 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.

↑