POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER— 510(k) K040332

Name: FDA 510(k) clearance K040332
Creator: U.S. Food and Drug Administration
Published: 2004-06-16

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K040332 for POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER, Substantially Equivalent on 2004-06-16. Applicant: Arkray, Inc.. Device class: 1.

Clearance details

Applicant: Arkray, Inc.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 2004-02-10
Decision date: 2004-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

Download summary PDF View on FDA.gov ↗

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