Cleared Traditional

K013152: ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

K013152 · Elan Holdings, Inc. · Chemistry
Nov 2001
Decision
50d
Days
Class 1
Risk

K013152 is an FDA 510(k) clearance for the ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on November 9, 2001, 50 days after receiving the submission on September 20, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K013152 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2001
Decision Date November 09, 2001
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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