Onclarity Self-Collection Kit
K-Number: K260184 · 2026-04-02
ApplicantBecton, Dickinson and Company
Decision Date2026-04-02
Product CodeSEP
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Onclarity Self-Collection Kit is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2026-04-02 under approval number K260184. The device is classified under product code SEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K260184.
When was Onclarity Self-Collection Kit approved by the FDA?
Onclarity Self-Collection Kit received FDA 510(k) clearance on 2026-04-02, under approval number K260184.
What company makes Onclarity Self-Collection Kit?
Onclarity Self-Collection Kit is manufactured by Becton, Dickinson and Company.
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.