FDA Product Code
FDA Product Code LIF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K091360 | CLEARFLUX DIALYZER REPROCESSING SYSTEM | Novaflux Technologies | 2010-11-03 | Traditional | PDF ↗ |
| K043126 | ASSIST HEADER CLEANER | Alcavis International, Inc. | 2005-02-03 | Traditional | PDF ↗ |
| K040660 | STERICHEK GLUTARALDEHYDE REAGENT STRIPS | Hach Company | 2004-11-15 | Traditional | PDF ↗ |
| K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM | Minntech Corp. | 2004-04-27 | Traditional | PDF ↗ |
| K024076 | MAKY 21.1 DIALYZER REPROCESSING SYSTEM | Hdc Maquinolas, LLC | 2003-09-26 | Traditional | PDF ↗ |
| K013713 | ARM AUTOMATIC REPROCESSING MACHINE | Alcavis International Incorporated | 2002-07-15 | Traditional | PDF ↗ |
| K992016 | AMUKIN D | Amuchina Intl., Inc. | 2000-01-10 | Traditional | PDF ↗ |
| K991851 | RENACLEAR DIALYZER CLEANING SYSTEM | Minntech Corp. | 1999-08-30 | Traditional | PDF ↗ |
| K974426 | POTENCY TEST STRIPS, INDICATOR TEST STRIPS | Reprocessing Products Corp | 1999-02-10 | Traditional | PDF ↗ |
| K974798 | STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS | Environmental Test Systems, Inc. | 1998-03-20 | Traditional | PDF ↗ |
| K970799 | ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) | Alexander Mfg. Co. | 1997-05-14 | Traditional | PDF ↗ |
| K955299 | DPS 4 DIALYZER PREPARATION SYSTEM | Seratronics, Inc. | 1996-10-21 | Traditional | PDF ↗ |
| K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K941757 | FORMALIN REUSE CART | National Medical Care, Medical Products Div., Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K941867 | RENALIN REUSE CART | Renal Scientific Service, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K944539 | DRS 4 ND DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K944492 | DIALYZER REPROCESSING SYSTEM | G.E.M. Water Systems | 1995-08-28 | Traditional | PDF ↗ |
| K923529 | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES | Seratronics, Inc. | 1994-08-29 | Traditional | PDF ↗ |
| K914123 | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS | Serim Research Corp. | 1992-04-09 | Traditional | PDF ↗ |
| K914580 | DRS-4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1992-02-24 | Traditional | PDF ↗ |
| K911628 | SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) | Serim Research Corp. | 1991-06-27 | Traditional | PDF ↗ |
| K911629 | SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) | Serim Research Corp. | 1991-06-27 | Traditional | PDF ↗ |
| K905217 | FORMASURE TEST REAGENT | Di-Chem, Inc. | 1991-04-09 | Traditional | PDF ↗ |
| K902227 | SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT | Serim Research Corp. | 1991-04-02 | Traditional | PDF ↗ |
| K904210 | RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 | Minntech Corp. | 1990-11-27 | Traditional | PDF ↗ |
| K900341 | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT | Serim Research Corp. | 1990-07-11 | Traditional | PDF ↗ |
| K884154 | TRANSLUMINAL ENDARTERECTOMY DEVICE | Thomas J. Fogarty, M.D. | 1988-12-27 | Traditional | PDF ↗ |
| K874573 | FRESENIUS PURISTERIL 340 (TM) | Seratronics, Inc. | 1988-04-25 | Traditional | PDF ↗ |
| K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR | Biodynamics Corp. | 1987-10-23 | Traditional | PDF ↗ |
| K870689 | HR-3000 REUSE ADAPTOR | Colorado Medical, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K870471 | MODIFIED HR-3000 REUSE ADAPTOR | Colorado Medical, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K860674 | DRS-4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K860026 | ULTRAMAX III, DIALYZER REPROCESSING DEVICE | Medicorp, Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K853817 | COBE REN NEW-D DISPENSING KIT | Cobe Laboratories, Inc. | 1985-10-17 | Traditional | PDF ↗ |
| K853413 | RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS | Alcide Corp. | 1985-09-06 | Traditional | PDF ↗ |
| K850799 | RINSE MACHINE KR-4 KIDNEY RINSE-4 | Medical Technologies International, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K850127 | FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G | Computer Dialysis Systems, Inc. | 1985-03-20 | Traditional | PDF ↗ |
| K843520 | WAREXIN RECOMMENDED ALTERNATIVE DIALYZ | Mesa Medical, Inc. | 1984-10-04 | Traditional | PDF ↗ |
| K841153 | ADAPTOR HR-3000 REUSE | Colorado Medical, Inc. | 1984-07-16 | Traditional | PDF ↗ |
| K842258 | RENATRON | Renal Systems, Inc. | 1984-07-06 | Traditional | PDF ↗ |
| K833128 | FORMA-FAS-TEST | Chemical Detection & Experimentation | 1984-06-27 | Traditional | PDF ↗ |
| K832705 | ULTRAMAX | Medicorp, Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K834447 | ECHO MM1000 | Mesa Medical, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K833181 | HPR HOME PATIENT RENATRON | Renal Systems, Inc. | 1983-10-27 | Traditional | PDF ↗ |
| K832230 | DIALYZER PREPARATION SYS DPS-4 | Seratronics, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K831132 | COMPUDIAL/KP-1 | Computer Dialysis Systems, Inc. | 1983-08-08 | Traditional | PDF ↗ |
| K830722 | SPORIDIDIN-D COLD STERILIZING/SOLUTION | Sporicidin Intl. | 1983-06-30 | Traditional | PDF ↗ |
| K830190 | AHR-3000 RE-USE ADAPTOR | Colorado Medical, Inc. | 1983-05-27 | Traditional | PDF ↗ |
| K830575 | RENALIN (TENTATIVE | Renal Systems, Inc. | 1983-03-31 | Traditional | PDF ↗ |
| K830574 | RENATRON DIALYZER REPROCESSING SYS | Renal Systems, Inc. | 1983-03-29 | Traditional | PDF ↗ |
| K821863 | DIALYZER REPROCESSING SYSTEM DRS-4 | Seratronics, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K821383 | ECHO, MODEL MM-1000 | Mesa Medical, Inc. | 1982-06-23 | Traditional | PDF ↗ |
| K820695 | AUTOMATIC DIALYZER REPROCESSOR #ADR-22 | Texas Medical Devices, Inc. | 1982-04-29 | Traditional | PDF ↗ |
| K813107 | COMPUDIAL/KP-1 | Computer Dialysis Systems, Inc. | 1982-03-23 | Traditional | PDF ↗ |
| K820221 | HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE | Renal Systems, Inc. | 1982-03-23 | Traditional | PDF ↗ |
| K812230 | MODEL RS 8300 | Renal Systems, Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K802828 | LIXIVITRON | United Medical | 1981-05-08 | Traditional | PDF ↗ |
Product code LIF · Class II · Gastroenterology, Urology. Data: openFDA.