Cleared Traditional

HDLC PRECIPITATING REAGENT

K982539 · Ac Biochemicals, Inc. · Chemistry

Sep 1998

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K982539 is an FDA 510(k) clearance for the HDLC PRECIPITATING REAGENT, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Ac Biochemicals, Inc. (Irvine, US). The FDA issued a Cleared decision on September 15, 1998, 56 days after receiving the submission on July 21, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K982539 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 1998
Decision Date	September 15, 1998
Days to Decision	56 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