Product code LIF
- Device name
- Dialyzer Reprocessing System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- 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 |
|---|---|---|---|
| K091360 | CLEARFLUX DIALYZER REPROCESSING SYSTEM | Novaflux Technologies | 2010-11-03 |
| K043126 | ASSIST HEADER CLEANER | Alcavis International, Inc. | 2005-02-03 |
| K040660 | STERICHEK GLUTARALDEHYDE REAGENT STRIPS | Hach Company | 2004-11-15 |
| K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM | Minntech Corp. | 2004-04-27 |
| K024076 | MAKY 21.1 DIALYZER REPROCESSING SYSTEM | Hdc Maquinolas, LLC | 2003-09-26 |
| K013713 | ARM AUTOMATIC REPROCESSING MACHINE | Alcavis International Incorporated | 2002-07-15 |
| K992016 | AMUKIN D | Amuchina Intl., Inc. | 2000-01-10 |
| K991851 | RENACLEAR DIALYZER CLEANING SYSTEM | Minntech Corp. | 1999-08-30 |
| K974426 | POTENCY TEST STRIPS, INDICATOR TEST STRIPS | Reprocessing Products Corp | 1999-02-10 |
| K974798 | STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS | Environmental Test Systems, Inc. | 1998-03-20 |
| K970799 | ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) | Alexander Mfg. Co. | 1997-05-14 |
| K955299 | DPS 4 DIALYZER PREPARATION SYSTEM | Seratronics, Inc. | 1996-10-21 |
| K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1996-04-18 |
| K941867 | RENALIN REUSE CART | Renal Scientific Service, Inc. | 1996-01-22 |
| K941757 | FORMALIN REUSE CART | National Medical Care, Medical Products Div., Inc. | 1996-01-22 |
| K944539 | DRS 4 ND DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1995-11-29 |
| K944492 | DIALYZER REPROCESSING SYSTEM | G.E.M. Water Systems | 1995-08-28 |
| K923529 | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES | Seratronics, Inc. | 1994-08-29 |
| K914123 | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS | Serim Research Corp. | 1992-04-09 |
| K914580 | DRS-4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1992-02-24 |
| K911628 | SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) | Serim Research Corp. | 1991-06-27 |
| K911629 | SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) | Serim Research Corp. | 1991-06-27 |
| K905217 | FORMASURE TEST REAGENT | Di-Chem, Inc. | 1991-04-09 |
| K902227 | SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT | Serim Research Corp. | 1991-04-02 |
| K904210 | RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 | Minntech Corp. | 1990-11-27 |
| K900341 | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT | Serim Research Corp. | 1990-07-11 |
| K884154 | TRANSLUMINAL ENDARTERECTOMY DEVICE | Thomas J. Fogarty, M.D. | 1988-12-27 |
| K874573 | FRESENIUS PURISTERIL 340 (TM) | Seratronics, Inc. | 1988-04-25 |
| K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR | Biodynamics Corp. | 1987-10-23 |
| K870689 | HR-3000 REUSE ADAPTOR | Colorado Medical, Inc. | 1987-04-10 |
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| 10677964009119 | Perassay 500 Peracetic Acid Test Strips | MEDIVATORS INC. | 2018-07-09 |
| 00677964007972 | Renalin Residual Test Strips | MEDIVATORS INC. | 2018-07-09 |
| 10677964007979 | Renalin Residual Test Strips | MEDIVATORS INC. | 2018-07-09 |
| 00898021000242 | PeraChek | Angelini Pharma Inc. | 2017-05-23 |
| 00898021000235 | PeraSidual | Angelini Pharma Inc. | 2017-05-23 |
| 00382830034456 | NATUS NEUROLOGY | NATUS NEUROLOGY INCORPORATED | 2017-03-17 |
| 00858293006120 | Micro-X | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |
| 00851575007150 | SteriChek® Peracetic Acid Reagent Strips | HACH COMPANY | 2016-09-23 |
| 00851575007044 | SteriChek® Peroxide Reagent Strips | HACH COMPANY | 2016-09-23 |
| 00851575007075 | SteriChek® Residual Peroxide Reagent Strips | HACH COMPANY | 2016-09-23 |
| M17451051 | Serim® GUARDIAN™ Residual Peroxide Test Strips | SERIM RESEARCH CORPORATION | 2016-09-08 |
| M17451052 | Serim® GUARDIAN™ Residual Peroxide Test Strips | SERIM RESEARCH CORPORATION | 2016-09-08 |
| M17451121 | Serim® GUARDIAN™ Residual Formaldehyde Test Strips | SERIM RESEARCH CORPORATION | 2016-09-08 |
| 00898021000037 | Maky 21.1 | Angelini Pharma Inc. | 2016-08-29 |