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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 K081213
Device Name BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
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 Received04/30/2008
Decision Date 08/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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