Cleared Traditional

HDL PRECIPITATING REAGENT

K954179 · Schiapparelli Biosystems, Inc. · Chemistry
Dec 1995
Decision
96d
Days
Class 1
Risk

About This 510(k) Submission

K954179 is an FDA 510(k) clearance for the HDL PRECIPITATING REAGENT, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on December 11, 1995, 96 days after receiving the submission on September 6, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K954179 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1995
Decision Date December 11, 1995
Days to Decision 96 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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