FDA 510(k)

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern

Número K: K172582 · 2018-05-24

Data da decisão2018-05-24

Código do produtoMOB

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern 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 2018-05-24 under 510(k) number K172582. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern?

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K172582.

When did EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern receive FDA 510(k) clearance?

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern received FDA 510(k) clearance on 2018-05-24, under 510(k) number K172582.

Who is the listed applicant for EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern?

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 EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern?

The FDA product code for EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern is MOB.

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Outros registros que listam Euroimmun Us, Inc. como candidato(a)

K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)

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Fonte oficial

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