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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 K072869
Device Name POINTCARE NOW SYSTEM
Applicant
Pointcare Technologies, Inc.
181 Cedar Hill St.
Marlborough,  MA  01752
Applicant Contact MAURICE N DOIRE
Correspondent
Pointcare Technologies, Inc.
181 Cedar Hill St.
Marlborough,  MA  01752
Correspondent Contact MAURICE N DOIRE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/09/2007
Decision Date 01/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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