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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, automated blood grouping and antibody
510(k) Number BK190434
Tradename ORTHO CONNECT™
Device Name System, Test, Automated Blood Grouping and Antibody
Original Applicant
STRATEC Biomedical UK Limited
third ave, centrum 100
burton upon trent
straffordshire,  DE14 2WD, 
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received12/19/2019
Decision Date 03/10/2020
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 No
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