Cleared Traditional

INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET

K934039 · Intersect Systems, Inc. · Chemistry
Nov 1993
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K934039 is an FDA 510(k) clearance for the INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on November 16, 1993, 90 days after receiving the submission on August 18, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K934039 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1993
Decision Date November 16, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LBR — Ldl & Vldl Precipitation, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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