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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 BK190379
Tradename DG Reader Net
Device Name Automated Blood Grouping and Antibody Test Systems
Original Applicant
Diagnostic Grifols, S. A.
passeig fluvial, 24
parets del valles,  08150,  SP
Current 510(k) Holder *
passeig fluvial, 24
parets del valles,  SPAIN  08150
No 510(k) contact with active listings identified
Regulation Number864.9175
Classification Product Code
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
* Based on currently available data in Establishment Registration and Device Listing