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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 centrifuge, cell-washing, automated for immuno-hematology
510(k) Number BK170141
Tradename UltraCW®II Automatic Cell Washing System
Device Name Centrifuge, Cell-Washing, Automated for Immunohematology
Original Applicant
Helmer Inc.
14400 bergen blvd
noblesville,  IN  46060
Regulation Number864.9285
Classification Product Code
KSN  
Date Received11/15/2017
Decision Date 01/22/2018
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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