GUARDIAN Quick Dip Residual Chlorine (5212)— 510(k) K253863
Substantially EquivalentSerim 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.
Summary
Serim Research's GUARDIAN Quick Dip Residual Chlorine (5212) is filed under FKJ, blood dialysis filters. The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 876.5820. It was a Traditional 510(k), and Gastroenterology and Urology is both the classification panel and the review panel.
Serim Research filed from Elkhart, Indiana. The decision came 104 calendar days after FDA received it (December 3, 2025 to March 17, 2026).
Clearance details
- Applicant
- Serim Research
- Product code
- Product code FKJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
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