Cleared Traditional

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

K992029 · Elan Diagnostics · Chemistry
Aug 1999
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K992029 is an FDA 510(k) clearance for the ATAC 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 Diagnostics (Brea, US). The FDA issued a Cleared decision on August 12, 1999, 57 days after receiving the submission on June 16, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K992029 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1999
Decision Date August 12, 1999
Days to Decision 57 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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