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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, donor, syphilis, antigens, treponemal
510(k) Number BK251285
Tradename Elecsys Syphilis
Device Name Test, Syphilis, Treponema (FOR DONOR TESTING)
Original Applicant
Roche Diagnostics
9115 hague rd
indianapolis,  IN  46256
Regulation Number866.3830
Classification Product Code
MYR  
Date Received09/26/2025
Decision Date 12/10/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
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 No
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