K182702

Substantially Equivalent

SEKURE Creatine Kinase Assay

Applicant: Sekisui Diagnostics P.E.I., Inc.
Product code: CGS
Advisory panel: Clinical Chemistry
Date received: 2018-09-27
Decision date: 2019-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown,, CA

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