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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 K093394
Device Name BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN GOLDSTEIN
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN GOLDSTEIN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/30/2009
Decision Date 04/08/2010
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
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