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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 K950057
Device Name TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP
Applicant
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Applicant Contact ANNA M LONGWELL
Correspondent
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Correspondent Contact ANNA M LONGWELL
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received01/05/1995
Decision Date 08/22/1995
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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