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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name flow cytometric reagents and accessories.
510(k) Number K141468
Device Name BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
Applicant
BD Biosciences
2350 Qume Dr.
San Jose,  CA  95131
Applicant Contact Terrance Thiel
Correspondent
BD Biosciences
2350 Qume Dr.
San Jose,  CA  95131
Correspondent Contact Terrance Thiel
Regulation Number864.5220
Classification Product Code
OYE  
Date Received06/03/2014
Decision Date 02/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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