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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose dehydrogenase, glucose
510(k) Number K122688
Device Name NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
Applicant
NOVA BIOMEDICAL CORPORATION
200 Prospect St
WALTHAM,  MA  02454
Applicant Contact PAUL W MACDONALD
Correspondent
NOVA BIOMEDICAL CORPORATION
200 Prospect St
WALTHAM,  MA  02454
Correspondent Contact PAUL W MACDONALD
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JIN   JJY   NBW  
Date Received09/04/2012
Decision Date 04/04/2013
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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