Cleared Traditional

CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL

K905296 · Cholestech Corp. · Chemistry

Dec 1990

Decision

29d

Days

Class 1

Risk

About This 510(k) Submission

K905296 is an FDA 510(k) clearance for the CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on December 26, 1990, 29 days after receiving the submission on November 27, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K905296 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 1990
Decision Date	December 26, 1990
Days to Decision	29 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