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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 K040725
Device Name BD FACSCANTO SYSTEM
Applicant
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Applicant Contact KIM FONDA
Correspondent
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Correspondent Contact KIM FONDA
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/22/2004
Decision Date 09/10/2004
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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