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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K091547
Device Name NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
Original Applicant
NOVA BIOMEDICAL CORP.
200 prospect st.
waltham,  MA  02454 9141
Original Contact paul macdonald
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JIN   JJX  
Date Received05/27/2009
Decision Date 01/15/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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