Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

K-Number: K172252 · 2018-04-20

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

Device Summary

EUROIMMUN IFA: Crithidia luciliae sensitive (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 K172252. 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 sensitive (anti-dsDNA) EUROPattern?

EUROIMMUN IFA: Crithidia luciliae sensitive (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 K172252.

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

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern received FDA 510(k) clearance on 2018-04-20, under approval number K172252.

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

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

What is the FDA product code for EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern?

The FDA product code for EUROIMMUN IFA: Crithidia luciliae sensitive (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 K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

View all 8 devices →

Related Devices (Code: KTL)

K172244EUROIMMUN IFA: Crithidia luciliae (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.

↑