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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 BK050003
Tradenames LIFECODES HLA-A Typing Kit for use with Luminex 100, LIFECODES HLA-B Typing Kit for use with Luminex 100, HLA-C Typing Kit for use with Luminex 100, LIFECODES HLA-DQB Typing Kit for use with Luminex 100 and LIFECODES HLA-DRB Typing Kit for use with Luminex 100
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Tepnel Lifecodes Corporation
550 west avenue
stamford,  CT  06902
Classification Product Code
MZI  
Date Received01/26/2005
Decision Date 07/18/2005
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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