Cleared Traditional

HDL SINGLES

K895381 · Trace America, Inc. · Chemistry
Nov 1989
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K895381 is an FDA 510(k) clearance for the HDL SINGLES, 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 November 8, 1989, 71 days after receiving the submission on August 29, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K895381 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1989
Decision Date November 08, 1989
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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