SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2— 510(k) K043268

Name: FDA 510(k) clearance K043268
Creator: U.S. Food and Drug Administration
Published: 2005-02-15

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K043268 for SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2, Substantially Equivalent on 2005-02-15. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CEI
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 2004-11-26
Decision date: 2005-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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