Cleared Traditional

CARESIDE TRGLYCERIDE

K020488 · Careside, Inc. · Chemistry
Apr 2002
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K020488 is an FDA 510(k) clearance for the CARESIDE TRGLYCERIDE, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on April 15, 2002, 61 days after receiving the submission on February 13, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K020488 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2002
Decision Date April 15, 2002
Days to Decision 61 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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