UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT— 510(k) K140829

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K140829 for UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT, Substantially Equivalent on 2014-07-14. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2014-04-01
Decision date: 2014-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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