FDA 510(k)

Anti-Borrelia burgdorferi US Westernblot (IgG)

Número K: K161513 · 2016-08-25

Data da decisão2016-08-25

Código do produtoLSR

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anti-Borrelia burgdorferi US Westernblot (IgG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun US. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161513. 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 Westernblot (IgG)?

Anti-Borrelia burgdorferi US Westernblot (IgG) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Euroimmun US. The 510(k) number is K161513.

When did Anti-Borrelia burgdorferi US Westernblot (IgG) receive FDA 510(k) clearance?

Anti-Borrelia burgdorferi US Westernblot (IgG) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161513.

Who is the listed applicant for Anti-Borrelia burgdorferi US Westernblot (IgG)?

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

What is the FDA product code for Anti-Borrelia burgdorferi US Westernblot (IgG)?

The FDA product code for Anti-Borrelia burgdorferi US Westernblot (IgG) is LSR.

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