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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 K960827
Device Name QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
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  
Date Received02/29/1996
Decision Date 05/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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