510(k) K253863
K253863 is an FDA 510(k) premarket notification submitted by Serim Research for the device "GUARDIAN Quick Dip Residual Chlorine (5212)". The FDA issued a decision of Substantially Equivalent on March 17, 2026. The device falls under product code FKJ (Filter, Blood, Dialysis), a Class II device regulated under 21 CFR 876.5820. Serim Research has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2026
- Date Received
- December 3, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Blood, Dialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type