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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name blood establishment computer software and accessories
510(k) Number BK200491
Tradename iWeBB electronic Laboratory Information System (iWeBB-eLIS)
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Carter BloodCare
2205 highway 121
bedford,  TX  76021
Regulation Number864.9165
Classification Product Code
MMH  
Date Received06/12/2020
Decision Date 07/29/2020
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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