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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 K900802
Device Name ANTI-HUMAN LEU-3A (CD4) FITC
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/20/1990
Decision Date 05/15/1990
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
Recalls CDRH Recalls
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