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FDA 510(k)

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

K-Number: K172582 · 2018-05-24

ApplicantEuroimmun Us, Inc.
Decision Date2018-05-24
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Euroimmun Us, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternK172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternK172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)K161513Anti-Borrelia burgdorferi US Westernblot (IgG)

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Related Devices (Code: MOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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