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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nad reduction/nadh oxidation, cpk or isoenzymes
510(k) Number K182702
Device Name SEKURE Creatine Kinase Assay
Applicant
SEKISUI DIAGNOSTICS P.E.I. INC.
70 Watts Avenue
Charlottetown,  CA C1E 2B9
Applicant Contact Jeanna MacLeod
Correspondent
SEKISUI DIAGNOSTICS P.E.I. INC.
70 Watts Avenue
Charlottetown,  CA C1E 2B9
Correspondent Contact Jeanna MacLeod
Regulation Number862.1215
Classification Product Code
CGS  
Date Received09/27/2018
Decision Date 04/17/2019
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
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