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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 BK970013
Tradename Donor-ID
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Digi-Trax Corporation
1550 barclay boulevard
buffalo grove,  IL  60089
Regulation Number864.9165
Classification Product Code
MMH  
Date Received06/02/1997
Decision Date 02/27/1998
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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