Cleared Traditional

ACE HDL-C REAGENT

K971526 · Schiapparelli Biosystems, Inc. · Chemistry

May 1997

Decision

23d

Days

Class 1

Risk

About This 510(k) Submission

K971526 is an FDA 510(k) clearance for the ACE HDL-C REAGENT, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 21, 1997, 23 days after receiving the submission on April 28, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K971526 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1997
Decision Date	May 21, 1997
Days to Decision	23 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