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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 BK241067
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Immucor GTI Diagnostics, Inc.
20925 crossroads circle
waukesha,  WI  53186
Classification Product Code
MZI  
Date Received04/11/2024
Decision Date 01/02/2025
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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