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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 BK020068
Tradename Pel Freez HLA High Resolution SSP UniTray
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Pel-Freez Clinical Systems, LLC
9099 n. deerbrook trail
brown deer,  WI  53223
Classification Product Code
MZI  
Date Received12/19/2002
Decision Date 01/14/2003
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
Type 510(k) Special
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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