Product code MSY
- Device name
- Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5665
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243898 | Chlorine Sentinel II | Nelson Environmental Technologies, Inc. | 2025-04-11 |
| K222167 | E-Z Chek Chlorine Residual Test Strips (K100-0101B) | Reprocessing Products Corporation (Rpc) | 2022-10-18 |
| K193169 | Nelson Sentinel Series Basic Chlorine Sentinel | Nelson Environmental Technologies, Inc. | 2020-10-29 |
| K132344 | E-Z CHECK OZONE TEST STRIPS | Reprocessing Products Corporation (Rpc) | 2014-02-25 |
| K090338 | ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE | Reprocessing Products Corp | 2009-05-08 |
| K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | Serim Research Corp. | 2008-05-06 |
| K002011 | GLUTARTEST 1 REAGENT STRIP | Integrated Biomedical Technology, Inc. | 2001-01-22 |
| K001194 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 2000-07-11 |
| K994226 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 2000-03-22 |
| K983997 | STERICHEK TOTAL CHLORINE TEST KIT | Environmental Test Systems, Inc. | 1999-04-02 |
| K974064 | MICRO X RESIDUAL TEST STRIPS | Reprocessing Products Corp | 1998-12-07 |
| K980164 | STERICHEK PERACETIC ACID REAGENT STRIPS | Environmental Test Systems, Inc. | 1998-04-16 |
| K971598 | STERICHEK CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 1997-07-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860006352165 | Chlorine Sentinel II | Nelson Environmental Technologies Inc | 2025-04-16 |
| 00860006352103 | Basic Chlorine Sentinel | Nelson Environmental Technologies Inc | 2022-07-06 |
| 00898021000242 | PeraChek | Angelini Pharma Inc. | 2017-05-23 |
| 00858293006083 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |
| 10858293006059 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |
| 00858293006113 | Micro-X | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |
| 00858293006328 | EZ-Chek | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |
| 00858293006052 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |
| 10858293006325 | EZ-Chek | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |
| 00858293006380 | EZ-Chek | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |
| 00858293006045 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-01-19 |
| 00858293006038 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-01-19 |
| 00858293006106 | EZ-Chek | REPROCESSING PRODUCTS CORPORATION | 2017-01-19 |
| 00858293006090 | EZ-Chek | REPROCESSING PRODUCTS CORPORATION | 2017-01-19 |
| 10858293006035 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-01-19 |
| 30858293006046 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-01-19 |
| 00858293006069 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-01-19 |
| 00858293006076 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-01-19 |
| 00851575007051 | SteriChek® Total Chlorine Test Kit | HACH COMPANY | 2016-11-23 |
| 00851575007020 | SteriChek® Residual Chlorine Reagent Strips | HACH COMPANY | 2016-11-23 |
| 00851575007068 | Sterichek® Total Chlorine Test Kit Refill | HACH COMPANY | 2016-11-23 |
| 00851575007150 | SteriChek® Peracetic Acid Reagent Strips | HACH COMPANY | 2016-09-23 |
| M1745167IN2 | Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips | SERIM RESEARCH CORPORATION | 2016-09-08 |
| M17451671 | Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips | SERIM RESEARCH CORPORATION | 2016-09-08 |