Cleared Traditional

WAKO HDL CHOLESTEROL TEST

K801834 · Wako Pure Chemical Industries, Ltd. · Chemistry

Sep 1980

Decision

46d

Days

Class 1

Risk

About This 510(k) Submission

K801834 is an FDA 510(k) clearance for the WAKO HDL CHOLESTEROL TEST, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Wako Pure Chemical Industries, Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980, 46 days after receiving the submission on August 1, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K801834 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 1980
Decision Date	September 16, 1980
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1475