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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 K946055
Device Name TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
Applicant
Becton Dickinson Immunocytometry Systems
2350 Qume Dr.
San Jose,  CA  95131 -1807
Applicant Contact ANNA LONGWELL
Correspondent
Becton Dickinson Immunocytometry Systems
2350 Qume Dr.
San Jose,  CA  95131 -1807
Correspondent Contact ANNA LONGWELL
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/28/1994
Decision Date 02/20/1996
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
Recalls CDRH Recalls
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