FKJ — Filter, Blood, Dialysis Class II
FDA product code FKJ covers "Filter, Blood, Dialysis", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FKJ
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253863 | serim research | GUARDIAN Quick Dip Residual Chlorine (5212) | March 17, 2026 |
| K901734 | serim research | SERIM RESIDUAL CHLORINE TEST KIT | September 13, 1990 |
| K841307 | bd becton dickinson vacutainer systems preanalytic | BBL GASPAK POUCH | May 14, 1984 |
| K820575 | computer dialysis systems | J.E.T. DIALYSIS SYSTEM | May 20, 1982 |
| K772040 | terumo america | TRANSDUCER PROTECTOR | November 28, 1977 |