K040767

Substantially Equivalent

SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT

Applicant: Beckman Coulter, Inc.
Product code: LBS
Advisory panel: Clinical Chemistry
Date received: 2004-03-25
Decision date: 2004-06-07
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.