510(k) K901734
- Device
- SERIM RESIDUAL CHLORINE TEST KIT
- Applicant
- SERIM RESEARCH CORP.
- 510(k) number
- K901734
- Product code
- FKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-13
- Date received
- 1990-04-17
- 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#
- Contact
- MICHAEL MCKENNA
- Address
- P.O. Box 4002 Elkhart IN US 46514 46514
FDA Registration Numbers#
- 1833387
- 2028411
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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases