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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
510(k) Number K050191
Device Name MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
Applicant
BECTON DICKINSON & CO.
2350 Qume Drive
San Jose,  CA  95131
Applicant Contact CARTER NAVARRO
Correspondent
BECTON DICKINSON & CO.
2350 Qume Drive
San Jose,  CA  95131
Correspondent Contact CARTER NAVARRO
Regulation Number862.2750
Classification Product Code
PER  
Date Received01/27/2005
Decision Date 02/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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