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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A1c Test System
510(k) Number K173206
Device Name SEKURE HbA1c Assay
Applicant
Sekisui Diagnostics P.E.I., Inc.
70 Watts Ave.
Charlottetown,,  CA C1E 2B9
Applicant Contact Penny White
Correspondent
Sekisui Diagnostics P.E.I., Inc.
70 Watts Ave.
Charlottetown,,  CA C1E 2B9
Correspondent Contact Penny White
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received10/02/2017
Decision Date 07/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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