Cleared Traditional

COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

K063150 · Thermo Electron OY · Immunology
Mar 2007
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K063150 is an FDA 510(k) clearance for the COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on March 19, 2007, 154 days after receiving the submission on October 16, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K063150 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2006
Decision Date March 19, 2007
Days to Decision 154 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CZW — Complement C3, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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