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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 K122307
Model DIAVUE PRUDENTIAL
Device Name DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
Applicant
BIOCARE CORPORATION
4f, no.12, lane 5, sec. 2
nashan rd lujihu township
taoyuan county, 
Contact shuchi chang
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received08/01/2012
Decision Date 04/05/2013
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
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