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FDA 510(k)

ADVIA Centaur® TSH3-Ultra II (TSH3ULII)

K-Number: K233050 · 2024-04-04

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2024-04-04
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur® TSH3-Ultra II (TSH3ULII) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-04-04 under approval number K233050. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur® TSH3-Ultra II (TSH3ULII)?

ADVIA Centaur® TSH3-Ultra II (TSH3ULII) is a medical device that received FDA 510(k) clearance on 2024-04-04. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K233050.

When was ADVIA Centaur® TSH3-Ultra II (TSH3ULII) approved by the FDA?

ADVIA Centaur® TSH3-Ultra II (TSH3ULII) received FDA 510(k) clearance on 2024-04-04, under approval number K233050.

What company makes ADVIA Centaur® TSH3-Ultra II (TSH3ULII)?

ADVIA Centaur® TSH3-Ultra II (TSH3ULII) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur® TSH3-Ultra II (TSH3ULII)?

The FDA product code for ADVIA Centaur® TSH3-Ultra II (TSH3ULII) is JLW.

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Related Devices (Code: JLW)

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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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