510(k) K253863
- Device
- GUARDIAN™ Quick Dip Residual Chlorine (5212)
- Applicant
- Serim Research
- 510(k) number
- K253863
- Product code
- FKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-17
- Date received
- 2025-12-03
- Regulation
- 876.5820
- Classification name
- Filter, Blood, Dialysis
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Amy Sheets
- Address
- 3506 Reedy Dr. Elkhart IN US 46514 46514
FDA Registration Numbers#
- 1833387
- 2028411
Source Documents#
Other 510(k) Records For Product Code FKJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901734 | SERIM RESIDUAL CHLORINE TEST KIT | Serim Research Corp. | 1990-09-13 |
| K841307 | BBL GASPAK POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-14 |
| K820575 | J.E.T. DIALYSIS SYSTEM | Computer Dialysis Systems, Inc. | 1982-05-20 |
| K772040 | TRANSDUCER PROTECTOR | Terumo America, Inc. | 1977-11-28 |