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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name centrifuge, blood-bank for in vitro diagnostic use
510(k) Number BK920034
Tradename Ortho BioVue System
Device Name Centrifuge, Blood Bank for in vitro Diagnostic Use
Original Applicant
Ortho-Clinical Diagnostics, Inc.
1001 u.s. highway 202
raritan,  NJ  08869 0606
Regulation Number864.9275
Classification Product Code
KSO  
Date Received11/06/1992
Decision Date 05/09/1995
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 Yes
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