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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 BK170019
Tradename IH-1000 (Model# 001100)
Device Name System, Test, Automated Blood Grouping and Antibody
Original Applicant
Bio-Rad Medical Diagnostics GmbH
industriestrasse 1
dreieich,  63303, 
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received03/06/2017
Decision Date 05/05/2017
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 Yes
In Vitro Product Yes
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