Cleared Traditional

Triglycerides

K150819 · Randox Laboratories Limited · Chemistry
Aug 2015
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K150819 is an FDA 510(k) clearance for the Triglycerides, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on August 6, 2015, 132 days after receiving the submission on March 27, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K150819 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2015
Decision Date August 06, 2015
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDT — Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1705

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