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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 BK940010
Tradename CAPTIA TM Syphilis-G
Device Name Test, Syphilis, Treponema (FOR DONOR TESTING)
Original Applicant
Mercia Diagnostics Limited
mercia house, broadford park
shalford, guildford gu4 8ew, 
Regulation Number866.3830
Classification Product Code
MYR  
Date Received02/22/1994
Decision Date 01/03/1995
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 Yes
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