FDA 510(k)

Onclarity™ Self-Collection Kit

Número K: K260184 · 2026-04-02

Data da decisão2026-04-02

Código do produtoSEP

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Onclarity™ Self-Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K260184. The device is classified under product code SEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Onclarity™ Self-Collection Kit?

Onclarity™ Self-Collection Kit is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K260184.

When did Onclarity™ Self-Collection Kit receive FDA 510(k) clearance?

Onclarity™ Self-Collection Kit received FDA 510(k) clearance on 2026-04-02, under 510(k) number K260184.

Who is the listed applicant for Onclarity™ Self-Collection Kit?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Onclarity™ Self-Collection Kit?

The FDA product code for Onclarity™ Self-Collection Kit is SEP.

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