510(k) K062746

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 by Medicon Hellas S.A — Product Code DBF

K062746 is an FDA 510(k) premarket notification submitted by Medicon Hellas S.A for the device "FERRITIN-LATEX, MODELS 1418-2070, 1418-0279". The FDA issued a decision of Substantially Equivalent on November 20, 2006. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Medicon Hellas S.A has at least 2 other 510(k) clearances on record.