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

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..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LBS
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 ↗

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