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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 BK150343
Tradename LIFECODES MATCH IT! DNA Software v1.2
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Immucor Transplant Diagnostics, Inc.
550 west avenue
stamford,  CT  06902 6352
Classification Product Code
MZI  
Date Received11/17/2015
Decision Date 05/11/2016
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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