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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 K970742
Device Name TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
Applicant
Becton Dickinson Immunocytometry Systems
2350 Qume Dr.
San Jose,  CA  95131
Applicant Contact ANNA LONGWELL, ESQ.
Correspondent
Becton Dickinson Immunocytometry Systems
2350 Qume Dr.
San Jose,  CA  95131
Correspondent Contact ANNA LONGWELL, ESQ.
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/28/1997
Decision Date 10/22/1997
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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