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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 BK130009
Tradename LABScreen® for use with LABScan(TM) 3D
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
One Lambda, Inc
21001 kittridge st
canoga park,  CA  91303
Classification Product Code
MZI  
Date Received03/08/2013
Decision Date 11/06/2013
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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