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FDA 510(k)

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

K-Number: K172244 · 2018-04-20

ApplicantEuroimmun Us, Inc.
Decision Date2018-04-20
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) 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 2018-04-20 under 510(k) number K172244. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern?

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K172244.

When did EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern receive FDA 510(k) clearance?

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern received FDA 510(k) clearance on 2018-04-20, under 510(k) number K172244.

Who is the listed applicant for EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) 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: Crithidia luciliae (anti-dsDNA) EUROPattern?

The FDA product code for EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern is KTL.

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)K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternK172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternK172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)K161513Anti-Borrelia burgdorferi US Westernblot (IgG)

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Related Devices (Code: KTL)

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.

K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus ScientificK203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc.K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc.

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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