K142985

Substantially Equivalent

UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator

Applicant: Beckman Coulter, Inc.
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2014-10-16
Decision date: 2015-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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