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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 BK820009
Tradename Anti-HLA Leukocyte Typing Serum
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Biotest-Serum-Institut GmbH
flughafenstrasse 4
6000 frankfurt/main 73, 
Classification Product Code
MZI  
Date Received11/12/1982
Decision Date 01/20/1983
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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