MSY · Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Gastroenterology, Urology · 21 CFR 876.5665 · Class 2
Overview
| Product Code | MSY |
|---|---|
| Device Name | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Regulation | 21 CFR 876.5665 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Life-Sustaining | Yes |
Identification
A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
Classification Rationale
Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243898 | Chlorine Sentinel II | Nelson Environmental Technologies, Inc. | Apr 11, 2025 | SESE |
| K222167 | E-Z Chek Chlorine Residual Test Strips (K100-0101B) | Reprocessing Products Corporation (Rpc) | Oct 18, 2022 | SESE |
| K193169 | Nelson Sentinel Series Basic Chlorine Sentinel | Nelson Environmental Technologies, Inc. | Oct 29, 2020 | SESE |
| K132344 | E-Z CHECK OZONE TEST STRIPS | Reprocessing Products Corporation (Rpc) | Feb 25, 2014 | SESE |
| K090338 | ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE | Reprocessing Products Corp | May 8, 2009 | SESE |
| K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | Serim Research Corp. | May 6, 2008 | SESE |
| K002011 | GLUTARTEST 1 REAGENT STRIP | Integrated Biomedical Technology, Inc. | Jan 22, 2001 | SESE |
| K001194 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | Jul 11, 2000 | SESE |
| K994226 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | Mar 22, 2000 | SESE |
| K983997 | STERICHEK TOTAL CHLORINE TEST KIT | Environmental Test Systems, Inc. | Apr 2, 1999 | SESE |
| K974064 | MICRO X RESIDUAL TEST STRIPS | Reprocessing Products Corp | Dec 7, 1998 | SESE |
| K980164 | STERICHEK PERACETIC ACID REAGENT STRIPS | Environmental Test Systems, Inc. | Apr 16, 1998 | SESE |
| K971598 | STERICHEK CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | Jul 18, 1997 | SESE |
Top Applicants
- Environmental Test Systems, Inc. — 5 clearances
- Nelson Environmental Technologies, Inc. — 2 clearances
- Reprocessing Products Corp — 2 clearances
- Reprocessing Products Corporation (Rpc) — 2 clearances
- Integrated Biomedical Technology, Inc. — 1 clearance
