Cleared Traditional

TRIGLYCERIDE REAGENT SET

K821205 · Omega Medical Electronics · Chemistry
Jul 1982
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K821205 is an FDA 510(k) clearance for the TRIGLYCERIDE REAGENT SET, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982, 84 days after receiving the submission on April 27, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K821205 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1982
Decision Date July 20, 1982
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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