PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS— 510(k) K063145

Name: FDA 510(k) clearance K063145
Creator: U.S. Food and Drug Administration
Published: 2007-10-17

Substantially Equivalent

Thermo Electron OY

FDA 510(k) clearance K063145 for PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS, Substantially Equivalent on 2007-10-17. Applicant: Thermo Electron OY. Device class: 2.

Clearance details

Applicant: Thermo Electron OY
Product code: Code DIP
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 2006-10-16
Decision date: 2007-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

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