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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 K945205
Device Name QBC ACCUTUBE
Applicant
Becton Dickinson Diagnostic Instrument Systems
7loveton Cir.
Sparks,  MD  21152
Applicant Contact DENNIS MERTZ
Correspondent
Becton Dickinson Diagnostic Instrument Systems
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact DENNIS MERTZ
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/25/1994
Decision Date 09/25/1995
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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