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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
510(k) Number K260184
Device Name Onclarity™ Self-Collection Kit
Applicant
Becton, Dickinson and Company
7loveton Cir.
Sparks,  MD  21152
Applicant Contact Joseph Basore
Correspondent
Becton, Dickinson and Company
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact Joseph Basore
Classification Product Code
SEP  
Date Received01/21/2026
Decision Date 04/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT06498661
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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