FDA 510(k)

GUARDIAN™ Quick Dip Residual Chlorine (5212)

K-번호: K253863 · 2026-03-17

결정일2026-03-17

제품 코드FKJ

자문 위원회GU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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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K251035DISINTEK™ PA Test Strips

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