Cleared Traditional

PARAMAX CHOLESTEROL REAGENT

K872050 · American Dade · Chemistry

Jul 1987

Decision

40d

Days

Class 1

Risk

About This 510(k) Submission

K872050 is an FDA 510(k) clearance for the PARAMAX CHOLESTEROL REAGENT, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on July 7, 1987, 40 days after receiving the submission on May 28, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K872050 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 1987
Decision Date	July 07, 1987
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

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