SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL— 510(k) K042443

Name: FDA 510(k) clearance K042443
Creator: U.S. Food and Drug Administration
Published: 2004-11-24

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K042443 for SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL, Substantially Equivalent on 2004-11-24. Applicant: Arkray, Inc.. Device class: 1.

Clearance details

Applicant: Arkray, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2004-09-09
Decision date: 2004-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

Download summary PDF View on FDA.gov ↗

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