Cleared Traditional

Cholesterol

K150654 · Randox Laboratories, Ltd. · Chemistry
Sep 2015
Decision
200d
Days
Class 1
Risk

About This 510(k) Submission

K150654 is an FDA 510(k) clearance for the Cholesterol, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on September 29, 2015, 200 days after receiving the submission on March 13, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K150654 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2015
Decision Date September 29, 2015
Days to Decision 200 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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