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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 BK050012
Tradenames Dynal RELI SSO HLA-DRB1 Typing Kit -, For Use as a manual asssay or with the AutoRELI Instrument
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 Received04/12/2005
Decision Date 05/18/2005
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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