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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 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 2025-12-04 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K250816.

When did ADVIA Centaur Anti-Thyroglobulin II (aTgII) receive FDA 510(k) clearance?

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

Who is the listed applicant for ADVIA Centaur Anti-Thyroglobulin II (aTgII)?

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-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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