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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uric Acid Test System For At Home Prescription Use
510(k) Number K160990
Device Name Nova Max Uric Acid Monitoring System
Applicant
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Applicant Contact ELIZA WANG
Correspondent
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Correspondent Contact ELIZA WANG
Regulation Number862.1775
Classification Product Code
PTC  
Date Received04/08/2016
Decision Date 04/11/2017
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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