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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 a medical device manufactured by Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2018-04-20 under approval 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. It is manufactured by Euroimmun Us, Inc.. The 510(k) number is K172244.

When was EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern approved by the FDA?

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

What company makes EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern?

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern is manufactured by Euroimmun Us, Inc..

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 Devices by Euroimmun Us, Inc.

K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM) K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG) K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

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Related Devices (Code: KTL)

K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc. K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc. K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus Scientific K203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.

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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