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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 test, qualitative, for hla, non-diagnostic
510(k) Number BK130028
Tradename Biofortuna Ltd. SSPGo HLA Typing Kit
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Biofortuna LTD
1 hawkshead road
croft business park
wirral
Merseyside,  CH62 3RJ, 
Classification Product Code
MZI  
Date Received06/20/2013
Decision Date 12/19/2013
Decision substantially equivalent (SE)
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 Yes
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