Cleared Traditional

INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT

K870828 · Intersect Systems, Inc. · Chemistry
Mar 1987
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K870828 is an FDA 510(k) clearance for the INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on March 13, 1987, 10 days after receiving the submission on March 3, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K870828 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1987
Decision Date March 13, 1987
Days to Decision 10 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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