Cleared Traditional

K880176 - HDL CHOLESTEROL PRECIPITATING REAGENT
(FDA 510(k) Clearance)

K880176 · Tech-Co, Inc. · Chemistry
Feb 1988
Decision
34d
Days
Class 1
Risk

K880176 is an FDA 510(k) clearance for the HDL CHOLESTEROL PRECIPITATING REAGENT. This device is classified as a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR).

Submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on February 18, 1988, 34 days after receiving the submission on January 15, 1988.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K880176 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1988
Decision Date February 18, 1988
Days to Decision 34 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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