Cleared Traditional

TRIGLYCERIDES TEST KIT

K895952 · Elite Technology, Inc. · Chemistry
Jan 1990
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K895952 is an FDA 510(k) clearance for the TRIGLYCERIDES TEST KIT, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Elite Technology, Inc. (Canada M9w 5p1, CA). The FDA issued a Cleared decision on January 11, 1990, 92 days after receiving the submission on October 11, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K895952 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1989
Decision Date January 11, 1990
Days to Decision 92 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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