Cleared Traditional

HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)

K931773 · King Diagnostics, Inc. · Chemistry
Aug 1993
Decision
129d
Days
Class 1
Risk

About This 510(k) Submission

K931773 is an FDA 510(k) clearance for the HDL PRECIPITATING REAGENT (DEXTRAN SULFATE), a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 16, 1993, 129 days after receiving the submission on April 9, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K931773 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1993
Decision Date August 16, 1993
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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