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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 BK190379
Tradename DG Reader Net
Device Name Automated Blood Grouping and Antibody Test Systems
Original Applicant
Diagnostic Grifols, S. A.
passeig fluvial, 24
barcelona
parets del valles,  08150,  SP
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received07/31/2019
Decision Date 10/11/2019
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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