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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 K062087
Device Name BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
Applicant
BD Biosciences
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Applicant Contact CARTER NAVARRO
Correspondent
BD Biosciences
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Correspondent Contact CARTER NAVARRO
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received07/24/2006
Decision Date 09/14/2006
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
Recalls CDRH Recalls
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