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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, differential cell
510(k) Number BK120015
Tradename ADAM-rWBC
Device Name Counter, Differential Cell
Original Applicant
Nanoentek, Inc.
300 washington st., ste 416
newton,  MA  02458
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/20/2012
Decision Date 07/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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