Cleared Traditional

Direct LDL Cholesterol (LDL)

K161691 · Randox Laboratories Limited · Chemistry
Mar 2017
Decision
273d
Days
Class 1
Risk

About This 510(k) Submission

K161691 is an FDA 510(k) clearance for the Direct LDL Cholesterol (LDL), a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on March 20, 2017, 273 days after receiving the submission on June 20, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K161691 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2016
Decision Date March 20, 2017
Days to Decision 273 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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