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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K233581
Device Name VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Applicant
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend,  GB CF355PZ
Applicant Contact Rebecca Lewis
Correspondent
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend,  GB CF355PZ
Correspondent Contact Rebecca Lewis
Regulation Number862.1155
Classification Product Code
DHA  
Date Received11/07/2023
Decision Date 05/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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