Cleared Traditional

JAS HDL CHOLESTEROL (AUTOMATED) REAGENT

K021671 · Jas Diagnostics, Inc. · Chemistry

Jul 2002

Decision

59d

Days

Class 1

Risk

About This 510(k) Submission

K021671 is an FDA 510(k) clearance for the JAS HDL CHOLESTEROL (AUTOMATED) REAGENT, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on July 19, 2002, 59 days after receiving the submission on May 21, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K021671 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2002
Decision Date	July 19, 2002
Days to Decision	59 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