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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sparse sample pk profile and dosing software
510(k) Number BK170028
Tradename myPKFiT for ADVATE Version 2.0
Device Name Sparse Sample Pk Profile and Dosing Software
Original Applicant
Baxalta US Inc.
one baxter way
westlake village,  CA  91362
Regulation Number868.1890
Classification Product Code
PHY  
Date Received03/24/2017
Decision Date 12/14/2017
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
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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