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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 BK050073
Tradename BD HLA-B27 System
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
BD Biosciences
2350 qume drive
san jose,  CA  95131 1807
Classification Product Code
MZI  
Date Received11/28/2005
Decision Date 02/16/2006
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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