FDA Product Code
FDA Product Code FKJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253863 | GUARDIAN Quick Dip Residual Chlorine (5212) | Serim Research | 2026-03-17 | Traditional | PDF ↗ |
| K901734 | SERIM RESIDUAL CHLORINE TEST KIT | Serim Research Corp. | 1990-09-13 | Traditional | PDF ↗ |
| K841307 | BBL GASPAK POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-14 | Traditional | PDF ↗ |
| K820575 | J.E.T. DIALYSIS SYSTEM | Computer Dialysis Systems, Inc. | 1982-05-20 | Traditional | PDF ↗ |
| K772040 | TRANSDUCER PROTECTOR | Terumo America, Inc. | 1977-11-28 | Traditional | PDF ↗ |
Product code FKJ · Class II · Gastroenterology, Urology. Data: openFDA.