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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
7 LOVETON CIRCLE
SPARKS,  MD  21152 -0999
Applicant Contact ROCKY GANSKE
Correspondent
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
7 LOVETON CIRCLE
SPARKS,  MD  21152 -0999
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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