Cleared Traditional

TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN

K962723 · Trace America, Inc. · Chemistry
Mar 1997
Decision
241d
Days
Class 1
Risk

About This 510(k) Submission

K962723 is an FDA 510(k) clearance for the TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on March 13, 1997, 241 days after receiving the submission on July 15, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K962723 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1996
Decision Date March 13, 1997
Days to Decision 241 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LBR — Ldl & Vldl Precipitation, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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