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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 BK060062
Tradename Olympus PK® TP Reagent System
Device Name System, Test, Automated Blood Grouping and Antibody
Original Applicant
Fujirebio Diagnostics, Inc.
201 great valley parkway
malvern,  PA  19355
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received12/01/2006
Decision Date 06/25/2007
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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