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

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..

Clearance details

Applicant: Arkray, Inc.
Product code: Code CHH
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.