Onclarity® Self-Collection Kit
K号: K260184 · 2026-04-02
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决定日期2026-04-02
产品代码SEP
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器械摘要
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.
常见问题
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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列明Becton, Dickinson and Company为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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