K120199

Substantially Equivalent

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

Applicant: Beckman Coulter, Inc.
Product 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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