Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin— 510(k) K200898

Name: FDA 510(k) clearance K200898
Creator: U.S. Food and Drug Administration
Published: 2021-09-21

Substantially Equivalent

Medicon Hellas S.A

FDA 510(k) clearance K200898 for Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin, Substantially Equivalent on 2021-09-21. Applicant: Medicon Hellas S.A. Device class: 2.

Clearance details

Applicant: Medicon Hellas S.A
Product code: Code CIX
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 2020-04-03
Decision date: 2021-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gerakas, GR

Download summary PDF View on FDA.gov ↗

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