Cleared Traditional

PICCOLO HDL TEST SYSTEM

K023640 · Abaxis, Inc. · Chemistry

Jan 2003

Decision

86d

Days

Class 1

Risk

About This 510(k) Submission

K023640 is an FDA 510(k) clearance for the PICCOLO HDL TEST SYSTEM, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on January 24, 2003, 86 days after receiving the submission on October 30, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K023640 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 2002
Decision Date	January 24, 2003
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

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