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FDA 510(k)

ADVIA Centaur Anti-Thyroglobulin II (aTgII)

K-Number: K250816 · 2025-12-04

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2025-12-04
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Anti-Thyroglobulin II (aTgII) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-12-04 under approval number K250816. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Anti-Thyroglobulin II (aTgII)?

ADVIA Centaur Anti-Thyroglobulin II (aTgII) is a medical device that received FDA 510(k) clearance on 2025-12-04. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K250816.

When was ADVIA Centaur Anti-Thyroglobulin II (aTgII) approved by the FDA?

ADVIA Centaur Anti-Thyroglobulin II (aTgII) received FDA 510(k) clearance on 2025-12-04, under approval number K250816.

What company makes ADVIA Centaur Anti-Thyroglobulin II (aTgII)?

ADVIA Centaur Anti-Thyroglobulin II (aTgII) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur Anti-Thyroglobulin II (aTgII)?

The FDA product code for ADVIA Centaur Anti-Thyroglobulin II (aTgII) is JNL.

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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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