FDA 510(k)

N Latex FLC kappa, N Latex FLC lambda

Número K: K190879 · 2019-05-03

RequerenteSiemens Healthcare Diagnostics Products GmbH

Data da decisão2019-05-03

Código do produtoDFH

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

N Latex FLC kappa, N Latex FLC lambda is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190879. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the N Latex FLC kappa, N Latex FLC lambda?

N Latex FLC kappa, N Latex FLC lambda is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K190879.

When did N Latex FLC kappa, N Latex FLC lambda receive FDA 510(k) clearance?

N Latex FLC kappa, N Latex FLC lambda received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190879.

Who is the listed applicant for N Latex FLC kappa, N Latex FLC lambda?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N Latex FLC kappa, N Latex FLC lambda?

The FDA product code for N Latex FLC kappa, N Latex FLC lambda is DFH.

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