COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL— 510(k) K063150

Name: FDA 510(k) clearance K063150
Creator: U.S. Food and Drug Administration
Published: 2007-03-19

Substantially Equivalent

Thermo Electron OY

FDA 510(k) clearance K063150 for COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL, Substantially Equivalent on 2007-03-19. Applicant: Thermo Electron OY. Device class: 2.

Clearance details

Applicant: Thermo Electron OY
Product code: Code CZW
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 2006-10-16
Decision date: 2007-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

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