Cleared Traditional

HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

K060318 · Horiba Abx · Chemistry
Aug 2006
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K060318 is an FDA 510(k) clearance for the HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on August 8, 2006, 181 days after receiving the submission on February 8, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K060318 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2006
Decision Date August 08, 2006
Days to Decision 181 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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