510(k) K191562

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor by HORIBA ABX SAS — Product Code DBF

K191562 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor". The FDA issued a decision of Substantially Equivalent on March 6, 2020. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.