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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name centrifuge, cell-washing, automated for immuno-hematology
510(k) Number BK130032
Tradename ORTHO (TM) Workstation
Device Name Centrifuge, Cell-Washing, Automated for Immunohematology
Original Applicant
Ortho-Clinical Diagnostics, Inc.
1001 u.s. highway 202
raritan,  NJ  08869 0606
Regulation Number864.9285
Classification Product Code
KSN  
Date Received07/01/2013
Decision Date 08/09/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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