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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 BK080022
Tradename Olerup SSP HLA Typing Kits
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Olerup SSP AB
hasselstigen 1
se 133 33 saltsjobaden
SWEDEN
Classification Product Code
MZI  
Date Received05/16/2008
Decision Date 02/20/2009
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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