K173206

Substantially Equivalent

SEKURE HbA1c Assay

Applicant: Sekisui Diagnostics P.E.I., Inc.
Product code: PDJ
Advisory panel: Clinical Chemistry
Date received: 2017-10-02
Decision date: 2018-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown,, CA

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