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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name system, test, automated blood grouping and antibody
510(k) Number BK060024
Tradenames Olympus Bromelin, Olympus PK7300 Automated Microplate System, Olympus System Control
Device Name System, Test, Automated Blood Grouping and Antibody
Original Applicant
Olympus America Inc., Diagnostic Systems Division
3131 west royal lane
irving,  TX  75063 3104
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received04/28/2006
Decision Date 05/14/2007
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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