510(k) K820575
- Device
- J.E.T. DIALYSIS SYSTEM
- Applicant
- COMPUTER DIALYSIS SYSTEMS, INC.
- 510(k) number
- K820575
- Product code
- FKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-20
- Date received
- 1982-03-03
- Regulation
- 876.5820
- Classification name
- Filter, Blood, Dialysis
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2028411
- 1833387
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253863 | GUARDIAN™ Quick Dip Residual Chlorine (5212) | Serim Research | 2026-03-17 |
| 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 |
| K772040 | TRANSDUCER PROTECTOR | Terumo America, Inc. | 1977-11-28 |
Legacy Summary#
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FDA Review#
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