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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 K071141
Device Name BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
Applicant
BD Biosciences
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Applicant Contact NOBUKO NAKAJIMA
Correspondent
BD Biosciences
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Correspondent Contact NOBUKO NAKAJIMA
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/24/2007
Decision Date 06/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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