Cleared Traditional

AUTOHDL CHOLESTEROL REAGENT SET

K992002 · Pointe Scientific, Inc., · Chemistry
Aug 1999
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K992002 is an FDA 510(k) clearance for the AUTOHDL CHOLESTEROL REAGENT SET, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on August 5, 1999, 51 days after receiving the submission on June 15, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K992002 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1999
Decision Date August 05, 1999
Days to Decision 51 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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