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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 BK230971
Tradename IH-500
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 Received07/13/2023
Decision Date 08/09/2023
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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