510(k) K141827

EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE by Euroimmun Us, Inc. — Product Code DHN

K141827 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE". The FDA issued a decision of Substantially Equivalent on April 17, 2015. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.