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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 BK030058
Tradename DYNAL RELI SSO HLA-Cw Typing Kit
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Dynal Biotech Ltd
11 bassendale road
croft busines park
bromborough, wirral, ch62 3ql, 
Classification Product Code
MZI  
Date Received09/29/2003
Decision Date 01/29/2004
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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