510(k) K060700

EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. by Euroimmun Us, LLC — Product Code MOB

K060700 is an FDA 510(k) premarket notification submitted by Euroimmun Us, LLC for the device "EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.". The FDA issued a decision of Substantially Equivalent on September 8, 2006. 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, LLC has at least 10 other 510(k) clearances on record.