FDA 510(k) Applications for Medical Device Product Code "LIF"
(Dialyzer Reprocessing System)

FDA 510(k) Number Applicant Device Name Decision Date
K013713 ALCAVIS INTERNATIONAL INCORPORATED ARM AUTOMATIC REPROCESSING MACHINE 07/15/2002
K043126 ALCAVIS INTERNATIONAL, INC. ASSIST HEADER CLEANER 02/03/2005
K853413 ALCIDE CORP. RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS 09/06/1985
K970799 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) 05/14/1997
K992016 AMUCHINA INTL., INC. AMUKIN D 01/10/2000
K874034 BIODYNAMICS CORP. ADR-22 AUTOMATIC DIALYZER REPROCESSOR 10/23/1987
K833128 CHEMICAL DETECTION & EXPERIMENTATION FORMA-FAS-TEST 06/27/1984
K853817 COBE LABORATORIES, INC. COBE REN NEW-D DISPENSING KIT 10/17/1985
K841153 COLORADO MEDICAL, INC. ADAPTOR HR-3000 REUSE 07/16/1984
K830190 COLORADO MEDICAL, INC. AHR-3000 RE-USE ADAPTOR 05/27/1983
K870689 COLORADO MEDICAL, INC. HR-3000 REUSE ADAPTOR 04/10/1987
K870471 COLORADO MEDICAL, INC. MODIFIED HR-3000 REUSE ADAPTOR 04/10/1987
K831132 COMPUTER DIALYSIS SYSTEMS, INC. COMPUDIAL/KP-1 08/08/1983
K813107 COMPUTER DIALYSIS SYSTEMS, INC. COMPUDIAL/KP-1 03/23/1982
K850127 COMPUTER DIALYSIS SYSTEMS, INC. FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G 03/20/1985
K905217 DI-CHEM, INC. FORMASURE TEST REAGENT 04/09/1991
K974798 ENVIRONMENTAL TEST SYSTEMS, INC. STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS 03/20/1998
K944492 G.E.M. WATER SYSTEMS DIALYZER REPROCESSING SYSTEM 08/28/1995
K040660 HACH COMPANY STERICHEK GLUTARALDEHYDE REAGENT STRIPS 11/15/2004
K024076 HDC MAQUINOLAS, LLC MAKY 21.1 DIALYZER REPROCESSING SYSTEM 09/26/2003
K850799 MEDICAL TECHNOLOGIES INTERNATIONAL, INC. RINSE MACHINE KR-4 KIDNEY RINSE-4 07/29/1985
K832705 MEDICORP, INC. ULTRAMAX 06/25/1984
K860026 MEDICORP, INC. ULTRAMAX III, DIALYZER REPROCESSING DEVICE 03/14/1986
K834447 MESA MEDICAL, INC. ECHO MM1000 03/23/1984
K821383 MESA MEDICAL, INC. ECHO, MODEL MM-1000 06/23/1982
K843520 MESA MEDICAL, INC. WAREXIN RECOMMENDED ALTERNATIVE DIALYZ 10/04/1984
K033505 MINNTECH CORP. RENACLEAN SH DIALYZER CLEANING SYSTEM 04/27/2004
K991851 MINNTECH CORP. RENACLEAR DIALYZER CLEANING SYSTEM 08/30/1999
K904210 MINNTECH CORP. RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 11/27/1990
K941757 NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. FORMALIN REUSE CART 01/22/1996
K091360 NOVAFLUX TECHNOLOGIES CLEARFLUX DIALYZER REPROCESSING SYSTEM 11/03/2010
K941867 RENAL SCIENTIFIC SERVICE, INC. RENALIN REUSE CART 01/22/1996
K833181 RENAL SYSTEMS, INC. HPR HOME PATIENT RENATRON 10/27/1983
K820221 RENAL SYSTEMS, INC. HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE 03/23/1982
K812230 RENAL SYSTEMS, INC. MODEL RS 8300 11/06/1981
K830575 RENAL SYSTEMS, INC. RENALIN (TENTATIVE 03/31/1983
K842258 RENAL SYSTEMS, INC. RENATRON 07/06/1984
K830574 RENAL SYSTEMS, INC. RENATRON DIALYZER REPROCESSING SYS 03/29/1983
K974426 REPROCESSING PRODUCTS CORP. POTENCY TEST STRIPS, INDICATOR TEST STRIPS 02/10/1999
K832230 SERATRONICS, INC. DIALYZER PREPARATION SYS DPS-4 10/14/1983
K821863 SERATRONICS, INC. DIALYZER REPROCESSING SYSTEM DRS-4 10/18/1982
K923529 SERATRONICS, INC. DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES 08/29/1994
K955299 SERATRONICS, INC. DPS 4 DIALYZER PREPARATION SYSTEM 10/21/1996
K931336 SERATRONICS, INC. DRS 4 DIALYZER REPROCESSING SYSTEM 04/18/1996
K944539 SERATRONICS, INC. DRS 4 ND DIALYZER REPROCESSING SYSTEM 11/29/1995
K860674 SERATRONICS, INC. DRS-4 DIALYZER REPROCESSING SYSTEM 04/07/1986
K914580 SERATRONICS, INC. DRS-4 DIALYZER REPROCESSING SYSTEM 02/24/1992
K874573 SERATRONICS, INC. FRESENIUS PURISTERIL 340 (TM) 04/25/1988
K911628 SERIM RESEARCH CORP. SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) 06/27/1991
K911629 SERIM RESEARCH CORP. SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) 06/27/1991
K902227 SERIM RESEARCH CORP. SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT 04/02/1991
K914123 SERIM RESEARCH CORP. SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS 04/09/1992
K900341 SERIM RESEARCH CORP. SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT 07/11/1990
K830722 SPORICIDIN INTL. SPORIDIDIN-D COLD STERILIZING/SOLUTION 06/30/1983
K820695 TEXAS MEDICAL DEVICES, INC. AUTOMATIC DIALYZER REPROCESSOR #ADR-22 04/29/1982
K884154 THOMAS J. FOGARTY, M.D. TRANSLUMINAL ENDARTERECTOMY DEVICE 12/27/1988
K802828 UNITED MEDICAL LIXIVITRON 05/08/1981
K830557 UNIVERSO S.A. ERG-JET ELECTRODE 03/31/1983


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