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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK230814
Tradename SmartDMS
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Life Plasma, Inc.
5438 perkiomen ave
reading,  PA  19606
Regulation Number864.9165
Classification Product Code
MMH  
Date Received06/12/2023
Decision Date 04/16/2024
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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