Cholesterol— 510(k) K150654

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K150654 for Cholesterol, Substantially Equivalent on 2015-09-29. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2015-03-13
Decision date: 2015-09-29
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.