Cleared Traditional

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279

K062746 · Medicon Hellas S.A · Immunology
Nov 2006
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K062746 is an FDA 510(k) clearance for the FERRITIN-LATEX, MODELS 1418-2070, 1418-0279, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Medicon Hellas S.A (Gerakas, Attiki, GR). The FDA issued a Cleared decision on November 20, 2006, 67 days after receiving the submission on September 14, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K062746 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2006
Decision Date November 20, 2006
Days to Decision 67 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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