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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 system, test, automated blood grouping and antibody
510(k) Number BK990043
Tradename B-Screen Solid Phase ELISA Assay for Detection of IgG Antibodies to HLA Class II Antigens
Device Name System, Test, Automated Blood Grouping and Antibody
Original Applicant
Genetic Testing Institute
150 n. patrick blvd.
brookfield,  WI  53045
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received12/03/1999
Decision Date 10/02/2000
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 Yes
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