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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 BK261329
Tradename Erytra Eflexis
Device Name System, Test, Automated Blood Grouping and Antibody
Original Applicant
Diagnostic Grifols, S.A.
passeig fluvial, 24
parets del valles,  70  Barcelona,  08150,  SPAIN
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received02/27/2026
Decision Date 05/21/2026
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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