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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 K971110
Device Name TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
Applicant
Becton Dickinson Immunocytometry Systems
2350 Qume Dr.
San Jose,  CA  95131
Applicant Contact CINDY MORROW
Correspondent
Becton Dickinson Immunocytometry Systems
2350 Qume Dr.
San Jose,  CA  95131
Correspondent Contact CINDY MORROW
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/26/1997
Decision Date 11/25/1997
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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