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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 BK960061
Tradename Biotest DQB-ELPHA
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
Biotest Diagnostics Corporation
66 ford road, suite 131
denville,  NJ  07834
Classification Product Code
MZI  
Date Received07/23/1996
Decision Date 08/04/1997
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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