FDA 510(k)

ADVIA Centaur Vitamin D Total (VitD)

Número K: K200509 · 2020-05-29

RequerenteSiemens Healthcare Diagnostics, Inc.

Data da decisão2020-05-29

Código do produtoMRG

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ADVIA Centaur Vitamin D Total (VitD) 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 2020-05-29 under 510(k) number K200509. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ADVIA Centaur Vitamin D Total (VitD)?

ADVIA Centaur Vitamin D Total (VitD) is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200509.

When did ADVIA Centaur Vitamin D Total (VitD) receive FDA 510(k) clearance?

ADVIA Centaur Vitamin D Total (VitD) received FDA 510(k) clearance on 2020-05-29, under 510(k) number K200509.

Who is the listed applicant for ADVIA Centaur Vitamin D Total (VitD)?

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 Vitamin D Total (VitD)?

The FDA product code for ADVIA Centaur Vitamin D Total (VitD) is MRG.

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Fonte oficial

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