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FDA 510(k)

EUROIMMUN Anti-BP230-CF ELISA (IgG)

K-Number: K193115 · 2020-09-17

ApplicantEuroimmun Us, Inc.
Decision Date2020-09-17
Product CodeOEG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN Anti-BP230-CF ELISA (IgG) 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 2020-09-17 under 510(k) number K193115. The device is classified under product code OEG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN Anti-BP230-CF ELISA (IgG)?

EUROIMMUN Anti-BP230-CF ELISA (IgG) is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K193115.

When did EUROIMMUN Anti-BP230-CF ELISA (IgG) receive FDA 510(k) clearance?

EUROIMMUN Anti-BP230-CF ELISA (IgG) received FDA 510(k) clearance on 2020-09-17, under 510(k) number K193115.

Who is the listed applicant for EUROIMMUN Anti-BP230-CF ELISA (IgG)?

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 Anti-BP230-CF ELISA (IgG)?

The FDA product code for EUROIMMUN Anti-BP230-CF ELISA (IgG) is OEG.

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.

K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternK172252EUROIMMUN 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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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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