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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK170102
Tradename Samplok Segment Sampler
Device Name Supplies, Blood-Bank
Original Applicant
ITL Corporation Pty, Ltd
41-45 tennant street
canberra act 2609, 
Regulation Number864.9050
Classification Product Code
KSS  
Date Received09/01/2017
Decision Date 11/28/2017
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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