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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 K955504
Device Name QBC ACCUREAD SYSTEM
Applicant
Becton Dickinson Diagnostic Instrument Systems
7loveton Cir.
Sparks,  MD  21152
Applicant Contact ROCKY GANSKE
Correspondent
Becton Dickinson Diagnostic Instrument Systems
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact ROCKY GANSKE
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Codes
GIO   GKG   JKA  
Date Received12/01/1995
Decision Date 02/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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