Triglycerides— 510(k) K150819

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K150819 for Triglycerides, Substantially Equivalent on 2015-08-06. Applicant: Randox Laboratories Limited. Device class: 1.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 2015-03-27
Decision date: 2015-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.