GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY— 510(k) K120199

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K120199 for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY, Substantially Equivalent on 2012-10-12. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2012-01-23
Decision date: 2012-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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