SEKURE Creatine Kinase Assay— 510(k) K182702

Substantially Equivalent

Sekisui Diagnostics P.E.I., Inc.

FDA 510(k) clearance K182702 for SEKURE Creatine Kinase Assay, Substantially Equivalent on 2019-04-17. Applicant: Sekisui Diagnostics P.E.I., Inc..

Clearance details

Applicant: Sekisui Diagnostics P.E.I., Inc.
Product code: 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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