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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion based, enzymatic, creatinine
510(k) Number K171059
Device Name Nova StatSensor Creatinine Hospital Meter System
Applicant
Nova Biomedical Corporation
200 Prospect Street
Waltham,  MA  02454
Applicant Contact Paul W. MacDonald
Correspondent
Nova Biomedical Corporation
200 Prospect Street
Waltham,  MA  02454
Correspondent Contact Paul W. MacDonald
Regulation Number862.1225
Classification Product Code
CGL  
Date Received04/10/2017
Decision Date 05/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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