Liquid CO2-2 (LCO2-2)— 510(k) K152085

Name: FDA 510(k) clearance K152085
Creator: U.S. Food and Drug Administration
Published: 2016-02-24

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K152085 for Liquid CO2-2 (LCO2-2), Substantially Equivalent on 2016-02-24. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2015-07-27
Decision date: 2016-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ardmore, GB

Download summary PDF View on FDA.gov ↗

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