Cleared Traditional

POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER

K040332 · Arkray, Inc. · Chemistry
Jun 2004
Decision
127d
Days
Class 1
Risk

About This 510(k) Submission

K040332 is an FDA 510(k) clearance for the POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on June 16, 2004, 127 days after receiving the submission on February 10, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number K040332 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2004
Decision Date June 16, 2004
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2170

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