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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 K071562
Device Name D3 HEMATOLOGY ANALYZER, MODEL D3
Applicant
Drew Scientific, Inc.
4230 Shilling Way
Dallas,  TX  75237
Applicant Contact ROGER BOURREE
Correspondent
Drew Scientific, Inc.
4230 Shilling Way
Dallas,  TX  75237
Correspondent Contact ROGER BOURREE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/07/2007
Decision Date 12/11/2007
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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