Cleared Traditional

ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS

K991789 · Elan Holdings, Inc. · Chemistry
Jul 1999
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K991789 is an FDA 510(k) clearance for the ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on July 9, 1999, 45 days after receiving the submission on May 25, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K991789 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 1999
Decision Date July 09, 1999
Days to Decision 45 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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