Cleared Traditional

CHOLESTEROL TEST KIT

K895951 · Elite Technology, Inc. · Chemistry
Feb 1990
Decision
128d
Days
Class 1
Risk

About This 510(k) Submission

K895951 is an FDA 510(k) clearance for the CHOLESTEROL TEST KIT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Elite Technology, Inc. (Canada M9w 5p1, CA). The FDA issued a Cleared decision on February 16, 1990, 128 days after receiving the submission on October 11, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K895951 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1989
Decision Date February 16, 1990
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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