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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 BK180301
Tradenames PK7400 TP HA Controls, PK7400 TP HA Reagent
Device Name Test, Syphilis, Treponema (FOR DONOR TESTING)
Original Applicant
Newmarket Biomedical Ltd
unit 1 lanwades business park
Kentford,  CB8 7PN, 
Regulation Number866.3830
Classification Product Code
MYR  
Secondary Product Code
GMR 
Date Received12/17/2018
Decision Date 08/01/2019
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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