FDA 510(k)

Atellica CH Enzymatic Creatinine_3 (ECre3)

Número K: K212223 · 2021-11-24

RequerenteSiemens Healthcare Diagnostics, Inc.

Data da decisão2021-11-24

Código do produtoJFY

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Atellica CH Enzymatic Creatinine_3 (ECre3) 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 2021-11-24 under 510(k) number K212223. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Atellica CH Enzymatic Creatinine_3 (ECre3)?

Atellica CH Enzymatic Creatinine_3 (ECre3) is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K212223.

When did Atellica CH Enzymatic Creatinine_3 (ECre3) receive FDA 510(k) clearance?

Atellica CH Enzymatic Creatinine_3 (ECre3) received FDA 510(k) clearance on 2021-11-24, under 510(k) number K212223.

Who is the listed applicant for Atellica CH Enzymatic Creatinine_3 (ECre3)?

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 Atellica CH Enzymatic Creatinine_3 (ECre3)?

The FDA product code for Atellica CH Enzymatic Creatinine_3 (ECre3) is JFY.

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Fonte oficial

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