Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

FDA 510(k) K200898 · Medicon Hellas S.A

Substantially Equivalent

510(k) numberK200898

Submission

Device name
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
Applicant
Medicon Hellas S.A
Gerakas, GR
Received
April 3, 2020
Decision date
September 21, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CIX – Bromcresol Green Dye-Binding, Albumin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1035
Specialty
Clinical Chemistry

Other 510(k)s with product code CIX

510(k)DeviceApplicantDecision
K251157Core MetabolicCIX · Traditional Truvian Health01/09/2026SE
K203248Albumin BCG2CIX · Traditional Abbott Ireland Diagnostics Division11/23/2021SE
K191316VITROS XT Chemistry Products ALB-TP SlidesCIX · Traditional Ortho-Clinical Diagnostics, Inc.06/07/2019SE
K170901Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400CIX · Traditional Biosystems S.A.04/13/2018SE
K131488Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…CIX · Traditional Alfa Wassermann Diagnostics Technologies, LLC08/19/2013SE
K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional Alfa Wassermann Diagnostic Technologies, Inc.07/13/2012SE
K110818Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional Polymedco, Inc.09/08/2011SE
K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…CIX · Traditional Elitechgroup06/21/2011SE
K101088Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous ReagentCIX · Traditional Medica Corp.04/04/2011SE
K080874Easyra Alb Reagent and Easyra Alp Reagent, Model 10218/10214, Easyra Ast Reagent, Model…CIX · Traditional Medica Corp.02/20/2009SE

More from Medica Corp.

510(k)DeviceDecision
K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional 08/09/2024SE
K062746Ferritin-Latex, Models 1418-2070, 1418-0279DBF · Traditional 11/20/2006SE

Questions and answers

When was Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin cleared by the FDA?

Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (K200898) received a 510(k) decision of Substantially Equivalent on September 21, 2021, 536 days after the submission was received.

What is the product code of K200898?

The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.