SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT— 510(k) K042459

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K042459 for SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT, Substantially Equivalent on 2004-11-17. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2004-09-10
Decision date: 2004-11-17
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.