Cleared Traditional

HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173

K905284 · Amresco, Inc. · Chemistry
Dec 1990
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K905284 is an FDA 510(k) clearance for the HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on December 11, 1990, 18 days after receiving the submission on November 23, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K905284 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1990
Decision Date December 11, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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