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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 BK940017
Tradename PRA-STAT Elisa/Panel React Anti-HLA Class I IgG Antibody
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
SangStat Medical Corporation
6300 dumbarton circle
freemont,  CA  94555
Classification Product Code
MZI  
Date Received04/13/1994
Decision Date 09/27/1994
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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