Cleared Traditional

SEKURE HbA1c Assay

K173206 · Sekisui Diagnostics P.E.I., Inc. · Chemistry

Jul 2018

Decision

283d

Days

Class 2

Risk

About This 510(k) Submission

K173206 is an FDA 510(k) clearance for the SEKURE HbA1c Assay, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on July 12, 2018, 283 days after receiving the submission on October 2, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K173206 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2017
Decision Date	July 12, 2018
Days to Decision	283 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PDJ — Hemoglobin A1c Test System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1373
Definition	Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.