Cleared Traditional

CHOLESTECH LDX SYSTEM

K954778 · Cholestech Corp. · Chemistry
Nov 1995
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K954778 is an FDA 510(k) clearance for the CHOLESTECH LDX SYSTEM, 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 November 24, 1995, 66 days after receiving the submission on September 19, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K954778 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1995
Decision Date November 24, 1995
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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

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