510(k) K200898

Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin by Medicon Hellas S.A — Product Code CIX

K200898 is an FDA 510(k) premarket notification submitted by Medicon Hellas S.A for the device "Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin". The FDA issued a decision of Substantially Equivalent on September 21, 2021. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Medicon Hellas S.A has at least 2 other 510(k) clearances on record.