Cleared Traditional

THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS

K041427 · Arkray, Inc. · Chemistry
Nov 2004
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K041427 is an FDA 510(k) clearance for the THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on November 24, 2004, 180 days after receiving the submission on May 28, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K041427 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2004
Decision Date November 24, 2004
Days to Decision 180 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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