Cleared Traditional

OLYMPUS TRIGLYCERIDE TEST SYSTEM

K063804 · Olympus America, Inc. · Chemistry
Mar 2007
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K063804 is an FDA 510(k) clearance for the OLYMPUS TRIGLYCERIDE TEST SYSTEM, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on March 23, 2007, 91 days after receiving the submission on December 22, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K063804 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2006
Decision Date March 23, 2007
Days to Decision 91 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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