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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 BK070011
Tradename XM-ONE Transplantation Cross Match
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
ABSORBER AB
drottninggatan 33
stockholm,  SE-103 95, 
Classification Product Code
MZI  
Date Received03/09/2007
Decision Date 07/29/2008
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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