K253863
- 510(k) number
- K253863
- Device name
- GUARDIAN Quick Dip Residual Chlorine (5212)
- Applicant
- Serim Research IN · US
- Product code
- FKJ — Filter, Blood, Dialysis
- Decision date
- 2026-03-17
- Date received
- 2025-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253863.pdf
Official FDA record: K253863
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.