Colli-Pee•Dx尿液收集套装
K号: K254121 · 2026-06-10
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决定日期2026-06-10
产品代码SIH
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器械摘要
Colli-Pee•Dx Urine Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is DNA Genotek, Inc.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K254121. The device is classified under product code SIH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Colli-Pee•Dx Urine Collection Kit?
Colli-Pee•Dx Urine Collection Kit is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is DNA Genotek, Inc.. The 510(k) number is K254121.
When did Colli-Pee•Dx Urine Collection Kit receive FDA 510(k) clearance?
Colli-Pee•Dx Urine Collection Kit received FDA 510(k) clearance on 2026-06-10, under 510(k) number K254121.
Who is the listed applicant for Colli-Pee•Dx Urine Collection Kit?
The FDA 510(k) record lists DNA Genotek, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Colli-Pee•Dx Urine Collection Kit?
The FDA product code for Colli-Pee•Dx Urine Collection Kit is SIH.
相关临床试验
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。
列明DNA Genotek, Inc.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。
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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