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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 BK120021
Tradename TPHA Screen
Device Name Test, Syphilis, Treponema (FOR DONOR TESTING)
Original Applicant
Immucor, Inc.
3130 gateway drive
p.o. box 5625
norcross,  GA  30091 5625
Regulation Number866.3830
Classification Product Code
MYR  
Date Received05/01/2012
Decision Date 10/24/2012
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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