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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
510(k) Number K241534
Device Name VITROS Immunodiagnostic Products Syphilis Reagent Pack
Applicant
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend,  GB CF35 5PZ
Applicant Contact Rebecca Lewis
Correspondent
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend,  GB CF35 5PZ
Correspondent Contact Rebecca Lewis
Regulation Number866.3830
Classification Product Code
LIP  
Date Received05/30/2024
Decision Date 08/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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