Cleared Traditional

ATAC PAK AST REAGENT KIT

K010488 · Elan Holdings, Inc. · Chemistry
Apr 2001
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K010488 is an FDA 510(k) clearance for the ATAC PAK AST REAGENT KIT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on April 9, 2001, 48 days after receiving the submission on February 20, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K010488 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2001
Decision Date April 09, 2001
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIT — Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100

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