GUARDIAN Quick Dip Residual Chlorine (5212)— 510(k) K253863

Name: FDA 510(k) clearance K253863
Creator: U.S. Food and Drug Administration
Published: 2026-03-17

Substantially Equivalent

Serim Research

FDA 510(k) clearance K253863 for GUARDIAN Quick Dip Residual Chlorine (5212), Substantially Equivalent on 2026-03-17. Applicant: Serim Research. Device class: 2.

Clearance details

Applicant: Serim Research
Product code: Code FKJ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-03
Decision date: 2026-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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