FDA 510(k)

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

Número K: K172722 · 2017-12-10

Data da decisão2017-12-10

Código do produtoLSR

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2017-12-10 under 510(k) number K172722. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is a medical device that received FDA 510(k) clearance on 2017-12-10. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K172722.

When did Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) receive FDA 510(k) clearance?

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) received FDA 510(k) clearance on 2017-12-10, under 510(k) number K172722.

Who is the listed applicant for Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

The FDA 510(k) record lists Euroimmun Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

The FDA product code for Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is LSR.

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Fonte oficial

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