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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 device, mixing and weighing, semi-automated
510(k) Number BK190429
Tradenames HemoMix 4 (Basic version), HemoMix 4 (Internal optional RFID installed version)
Device Name Device, Mixing and Weighing, Semi-automated
Original Applicant
Delcon S.r.l.
via zanica
grassobbio,  BG,  24050, 
Regulation Number864.9195
Classification Product Code
MYJ  
Date Received12/31/2019
Decision Date 01/30/2020
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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