GUARDIAN™ Quick Dip Residual Chlorine (5212)
K号: K253863 · 2026-03-17
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决定日期2026-03-17
产品代码FKJ
咨询委员会GU
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决定实质等同
器械摘要
GUARDIAN™ Quick Dip Residual Chlorine (5212) is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K253863. The device is classified under product code FKJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GUARDIAN™ Quick Dip Residual Chlorine (5212)?
GUARDIAN™ Quick Dip Residual Chlorine (5212) is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Serim Research. The 510(k) number is K253863.
When did GUARDIAN™ Quick Dip Residual Chlorine (5212) receive FDA 510(k) clearance?
GUARDIAN™ Quick Dip Residual Chlorine (5212) received FDA 510(k) clearance on 2026-03-17, under 510(k) number K253863.
Who is the listed applicant for GUARDIAN™ Quick Dip Residual Chlorine (5212)?
The FDA 510(k) record lists Serim Research as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GUARDIAN™ Quick Dip Residual Chlorine (5212)?
The FDA product code for GUARDIAN™ Quick Dip Residual Chlorine (5212) is FKJ.
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列明Serim Research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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