K042195

Substantially Equivalent

SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747

Applicant: Beckman Coulter, Inc.
Product code: LBS
Advisory panel: Clinical Chemistry
Date received: 2004-08-13
Decision date: 2004-09-16
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.