SEKURE HbA1c Assay— 510(k) K173206

Substantially Equivalent

Sekisui Diagnostics P.E.I., Inc.

FDA 510(k) clearance K173206 for SEKURE HbA1c Assay, Substantially Equivalent on 2018-07-12. Applicant: Sekisui Diagnostics P.E.I., Inc..

Clearance details

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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.