K143470

Substantially Equivalent

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set

Applicant: Diazyme Laboratories
Product code: GIS
Advisory panel: Hematology
Date received: 2014-12-05
Decision date: 2016-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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