FERRITIN-LATEX, MODELS 1418-2070, 1418-0279— 510(k) K062746

Name: FDA 510(k) clearance K062746
Creator: U.S. Food and Drug Administration
Published: 2006-11-20

Substantially Equivalent

Medicon Hellas S.A

FDA 510(k) clearance K062746 for FERRITIN-LATEX, MODELS 1418-2070, 1418-0279, Substantially Equivalent on 2006-11-20. Applicant: Medicon Hellas S.A. Device class: 2.

Clearance details

Applicant: Medicon Hellas S.A
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 2006-09-14
Decision date: 2006-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gerakas, Attiki, GR

Download summary PDF View on FDA.gov ↗

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