510(k) K172244

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern by Euroimmun Us, Inc. — Product Code KTL

K172244 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern". The FDA issued a decision of Substantially Equivalent on April 20, 2018. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.