Cleared Traditional

ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS

K000900 · Elan Holdings, Inc. · Chemistry
May 2000
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K000900 is an FDA 510(k) clearance for the ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on May 2, 2000, 42 days after receiving the submission on March 21, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K000900 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2000
Decision Date May 02, 2000
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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