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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 BK100024
Tradename Lab 21 TPHA OC Kit
Device Name Test, Syphilis, Treponema (FOR DONOR TESTING)
Original Applicant
Lab 21 Healthcare Ltd
184 cambridge science park
cambridge,  Cambridgeshire,  CB4 0GA, UK, 
Regulation Number866.3830
Classification Product Code
MYR  
Date Received03/25/2010
Decision Date 08/03/2010
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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