510(k) K083850

EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS by Euroimmun Us, Inc. — Product Code MOB

K083850 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS". The FDA issued a decision of Substantially Equivalent on May 20, 2009. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.