Cleared Traditional

AST REAGENT

K903829 · Amresco, Inc. · Chemistry
Sep 1990
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K903829 is an FDA 510(k) clearance for the AST REAGENT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on September 25, 1990, 35 days after receiving the submission on August 21, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K903829 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1990
Decision Date September 25, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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