Panels › Gastroenterology, Urology › Product code LIF · Class 2
Dialyzer Reprocessing System
Regulation 876.5820
0510(k)s in 12 months (57 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LIF
| Company | 510(k)s | Recalls |
|---|---|---|
| Seratronics, Inc. | 9 | 0 |
| Renal Systems, Inc. | 6 | 0 |
| Serim Research Corp. | 5 | 0 |
| Colorado Medical, Inc. | 4 | 0 |
| Computer Dialysis Systems, Inc. | 3 | 0 |
| Mesa Medical, Inc. | 3 | 0 |
| Minntech Corp. | 3 | 0 |
| Alcavis International Incorporated | 2 | 0 |
| Hach Company | 1 | 1 |
| Medicorp, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 3, 2010 | K091360 | CLEARFLUX DIALYZER REPROCESSING SYSTEM Novaflux Technologies | LIF |
| Feb 3, 2005 | K043126 | ASSIST HEADER CLEANER Alcavis International, Inc. | LIF |
| Nov 15, 2004 | K040660 | STERICHEK GLUTARALDEHYDE REAGENT STRIPS Hach Company | LIF |
| Apr 27, 2004 | K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM Minntech Corp. | LIF |
| Sep 26, 2003 | K024076 | MAKY 21.1 DIALYZER REPROCESSING SYSTEM Hdc Maquinolas, LLC | LIF |
| Jul 15, 2002 | K013713 | ARM AUTOMATIC REPROCESSING MACHINE Alcavis International Incorporated | LIF |
| Jan 10, 2000 | K992016 | AMUKIN D Amuchina Intl., Inc. | LIF |
| Aug 30, 1999 | K991851 | RENACLEAR DIALYZER CLEANING SYSTEM Minntech Corp. | LIF |
| Feb 10, 1999 | K974426 | POTENCY TEST STRIPS, INDICATOR TEST STRIPS Reprocessing Products Corp | LIF |
| Mar 20, 1998 | K974798 | STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS Environmental Test Systems, Inc. | LIF |
| May 14, 1997 | K970799 | ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) Alexander Mfg. Co. | LIF |
| Oct 21, 1996 | K955299 | DPS 4 DIALYZER PREPARATION SYSTEM Seratronics, Inc. | LIF |
| Apr 18, 1996 | K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. | LIF |
| Jan 22, 1996 | K941867 | RENALIN REUSE CART Renal Scientific Service, Inc. | LIF |
| Jan 22, 1996 | K941757 | FORMALIN REUSE CART National Medical Care, Medical Products Div., Inc. | LIF |
| Nov 29, 1995 | K944539 | DRS 4 ND DIALYZER REPROCESSING SYSTEM Seratronics, Inc. | LIF |
| Aug 28, 1995 | K944492 | DIALYZER REPROCESSING SYSTEM G.E.M. Water Systems | LIF |
| Aug 29, 1994 | K923529 | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES Seratronics, Inc. | LIF |
| Apr 9, 1992 | K914123 | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS Serim Research Corp. | LIF |
| Feb 24, 1992 | K914580 | DRS-4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. | LIF |
| Jun 27, 1991 | K911629 | SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) Serim Research Corp. | LIF |
| Jun 27, 1991 | K911628 | SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) Serim Research Corp. | LIF |
| Apr 9, 1991 | K905217 | FORMASURE TEST REAGENT Di-Chem, Inc. | LIF |
| Apr 2, 1991 | K902227 | SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT Serim Research Corp. | LIF |
| Nov 27, 1990 | K904210 | RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 Minntech Corp. | LIF |
| Jul 11, 1990 | K900341 | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT Serim Research Corp. | LIF |
| Dec 27, 1988 | K884154 | TRANSLUMINAL ENDARTERECTOMY DEVICE Thomas J. Fogarty, M.D. | LIF |
| Apr 25, 1988 | K874573 | FRESENIUS PURISTERIL 340 (TM) Seratronics, Inc. | LIF |
| Oct 23, 1987 | K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR Biodynamics Corp. | LIF |
| Apr 10, 1987 | K870689 | HR-3000 REUSE ADAPTOR Colorado Medical, Inc. | LIF |
| Apr 10, 1987 | K870471 | MODIFIED HR-3000 REUSE ADAPTOR Colorado Medical, Inc. | LIF |
| Apr 7, 1986 | K860674 | DRS-4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. | LIF |
| Mar 14, 1986 | K860026 | ULTRAMAX III, DIALYZER REPROCESSING DEVICE Medicorp, Inc. | LIF |
| Oct 17, 1985 | K853817 | COBE REN NEW-D DISPENSING KIT Cobe Laboratories, Inc. | LIF |
| Sep 6, 1985 | K853413 | RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS Alcide Corp. | LIF |
| Jul 29, 1985 | K850799 | RINSE MACHINE KR-4 KIDNEY RINSE-4 Medical Technologies International, Inc. | LIF |
| Mar 20, 1985 | K850127 | FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G Computer Dialysis Systems, Inc. | LIF |
| Oct 4, 1984 | K843520 | WAREXIN RECOMMENDED ALTERNATIVE DIALYZ Mesa Medical, Inc. | LIF |
| Jul 16, 1984 | K841153 | ADAPTOR HR-3000 REUSE Colorado Medical, Inc. | LIF |
| Jul 6, 1984 | K842258 | RENATRON Renal Systems, Inc. | LIF |
| Jun 27, 1984 | K833128 | FORMA-FAS-TEST Chemical Detection & Experimentation | LIF |
| Jun 25, 1984 | K832705 | ULTRAMAX Medicorp, Inc. | LIF |
| Mar 23, 1984 | K834447 | ECHO MM1000 Mesa Medical, Inc. | LIF |
| Oct 27, 1983 | K833181 | HPR HOME PATIENT RENATRON Renal Systems, Inc. | LIF |
| Oct 14, 1983 | K832230 | DIALYZER PREPARATION SYS DPS-4 Seratronics, Inc. | LIF |
| Aug 8, 1983 | K831132 | COMPUDIAL/KP-1 Computer Dialysis Systems, Inc. | LIF |
| Jun 30, 1983 | K830722 | SPORIDIDIN-D COLD STERILIZING/SOLUTION Sporicidin Intl. | LIF |
| May 27, 1983 | K830190 | AHR-3000 RE-USE ADAPTOR Colorado Medical, Inc. | LIF |
| Mar 31, 1983 | K830575 | RENALIN (TENTATIVE Renal Systems, Inc. | LIF |
| Mar 29, 1983 | K830574 | RENATRON DIALYZER REPROCESSING SYS Renal Systems, Inc. | LIF |
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