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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 K131301
Device Name BD FACS SAMPLE PREP ASSISTANT III
Applicant
BECTON DICKINSON & CO.
2350 Qume Drive
San Jose,  CA  95131
Applicant Contact KIMBERLY LIEDTKE
Correspondent
BECTON DICKINSON & CO.
2350 Qume Drive
San Jose,  CA  95131
Correspondent Contact KIMBERLY LIEDTKE
Regulation Number862.2750
Classification Product Code
PER  
Date Received05/07/2013
Decision Date 08/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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