Cleared Traditional

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 · Medicon Hellas S.A · Chemistry

Sep 2021

Decision

536d

Days

Class 2

Risk

About This 510(k) Submission

K200898 is an FDA 510(k) clearance for the Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Medicon Hellas S.A (Gerakas, GR). The FDA issued a Cleared decision on September 21, 2021, 536 days after receiving the submission on April 3, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number	K200898 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2020
Decision Date	September 21, 2021
Days to Decision	536 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF