510(k) K133083

DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET by Diazyme Laboratories — Product Code DBF

K133083 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET". The FDA issued a decision of Substantially Equivalent on June 24, 2014. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Diazyme Laboratories has at least 10 other 510(k) clearances on record.