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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 BK180229
Tradename HemoMix 3 with DCSX Software
Device Name Device, Mixing and Weighing, Semi-automated
Original Applicant
Delcon S.r.l.
via zanica
grassobbio,  BG,  24050,  ITALY
Regulation Number864.9195
Classification Product Code
MYJ  
Date Received07/10/2018
Decision Date 10/04/2018
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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