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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 K992849
Device Name QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
7 Loveton Circle
Sparks,  MD  21152 -0999
Applicant Contact MONICA E GIGUERE
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
7 Loveton Circle
Sparks,  MD  21152 -0999
Correspondent Contact MONICA E GIGUERE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received08/24/1999
Decision Date 09/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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