HDL CHOLESTEROL (HDLX) ASSAY— 510(k) K100010

Name: FDA 510(k) clearance K100010
Creator: U.S. Food and Drug Administration
Published: 2010-05-14

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K100010 for HDL CHOLESTEROL (HDLX) ASSAY, Substantially Equivalent on 2010-05-14. Applicant: Beckman Coulter, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2010-01-04
Decision date: 2010-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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