Cleared Traditional

TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL

K914511 · Technicon Instruments Corp. · Chemistry

Nov 1991

Decision

49d

Days

Class 1

Risk

About This 510(k) Submission

K914511 is an FDA 510(k) clearance for the TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on November 27, 1991, 49 days after receiving the submission on October 9, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K914511 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 1991
Decision Date	November 27, 1991
Days to Decision	49 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