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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 BK950005
Tradename GTI-HLA 1, Class I Antibody Screening Kit
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Genetic Testing Institute
1701 w. wisconsin avenue, suite 429
milwaukee,  WI  53233
Classification Product Code
MZI  
Date Received10/26/1994
Decision Date 05/19/1995
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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