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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name manual blood grouping and antibody test systems
510(k) Number BK120045
Tradename DG Spin
Device Name Manual blood grouping and antibody test systems
Original Applicant
Diagnostic Grifols, S. A.
passeig fluvial, 24
barcelona
parets del valles,  08150,  SPAIN
Regulation Number864.9175
Classification Product Code
PBC  
Date Received09/05/2012
Decision Date 07/19/2013
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 Yes
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