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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 BK090082
Tradename SGP Version 7.0 (Plasma Management System)
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Biomat USA, Inc.
1311 temple avenue
city of industry,  CA  91746
Regulation Number864.9165
Classification Product Code
MMH  
Date Received01/07/2010
Decision Date 10/01/2010
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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