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FDA 510(k)

GUARDIAN™ Quick Dip Residual Chlorine (5212)

K-Number: K253863 · 2026-03-17

Decision Date2026-03-17
Product CodeFKJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GUARDIAN™ Quick Dip Residual Chlorine (5212) is a medical device manufactured by Serim Research. It received FDA 510(k) clearance on 2026-03-17 under approval number K253863. The device is classified under product code FKJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Serim Research. The 510(k) number is K253863.

When was GUARDIAN™ Quick Dip Residual Chlorine (5212) approved by the FDA?

GUARDIAN™ Quick Dip Residual Chlorine (5212) received FDA 510(k) clearance on 2026-03-17, under approval number K253863.

What company makes GUARDIAN™ Quick Dip Residual Chlorine (5212)?

GUARDIAN™ Quick Dip Residual Chlorine (5212) is manufactured by Serim Research.

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.

Related Clinical Trials

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.