FDA 510(k)

ADVIA Centaur® TSH3-Ultra II (TSH3ULII)

Número K: K233050 · 2024-04-04

RequerenteSiemens Healthcare Diagnostics, Inc.

Data da decisão2024-04-04

Código do produtoJLW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ADVIA Centaur® TSH3-Ultra II (TSH3ULII) 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 2024-04-04 under 510(k) number K233050. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K233050.

When did ADVIA Centaur® TSH3-Ultra II (TSH3ULII) receive FDA 510(k) clearance?

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

Who is the listed applicant for ADVIA Centaur® TSH3-Ultra II (TSH3ULII)?

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® TSH3-Ultra II (TSH3ULII)?

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

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Dispositivos Relacionados (Código: JLW)

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