Cleared Traditional

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

K172252 · Euroimmun Us, Inc. · Immunology
Apr 2018
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K172252 is an FDA 510(k) clearance for the EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern, a Anti-dna Indirect Immunofluorescent Solid Phase (Class II — Special Controls, product code KTL), submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on April 20, 2018, 268 days after receiving the submission on July 26, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K172252 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2017
Decision Date April 20, 2018
Days to Decision 268 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code KTL — Anti-dna Indirect Immunofluorescent Solid Phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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