Cleared Traditional

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

K063086 · Thermo Electron OY · Immunology
Aug 2007
Decision
302d
Days
Class 2
Risk

About This 510(k) Submission

K063086 is an FDA 510(k) clearance for the TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on August 8, 2007, 302 days after receiving the submission on October 10, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K063086 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2006
Decision Date August 08, 2007
Days to Decision 302 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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