LIF · Class II · 21 CFR 876.5820

FDA Product Code LIF: Dialyzer Reprocessing System

Leading manufacturers include Seratronics, Inc., Renal Systems, Inc. and Serim Research Corp..

57
Total
57
Cleared
192d
Avg days
1981
Since

FDA 510(k) Cleared Dialyzer Reprocessing System Devices (Product Code LIF)

57 devices
1–24 of 57
Cleared Nov 03, 2010
CLEARFLUX DIALYZER REPROCESSING SYSTEM
K091360
Novaflux Technologies
Gastroenterology & Urology · 544d
Cleared Feb 03, 2005
ASSIST HEADER CLEANER
K043126
Alcavis International, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 27, 2004
RENACLEAN SH DIALYZER CLEANING SYSTEM
K033505
Minntech Corp.
Gastroenterology & Urology · 174d
Cleared Sep 26, 2003
MAKY 21.1 DIALYZER REPROCESSING SYSTEM
K024076
Hdc Maquinolas, LLC
Gastroenterology & Urology · 290d
Cleared Jul 15, 2002
ARM AUTOMATIC REPROCESSING MACHINE
K013713
Alcavis International Incorporated
Gastroenterology & Urology · 249d
Cleared Jan 10, 2000
AMUKIN D
K992016
Amuchina Intl., Inc.
Gastroenterology & Urology · 209d
Cleared Aug 30, 1999
RENACLEAR DIALYZER CLEANING SYSTEM
K991851
Minntech Corp.
Gastroenterology & Urology · 90d
Cleared Feb 10, 1999
POTENCY TEST STRIPS, INDICATOR TEST STRIPS
K974426
Reprocessing Products Corp
Gastroenterology & Urology · 471d
Cleared Mar 20, 1998
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
K974798
Environmental Test Systems, Inc.
Gastroenterology & Urology · 88d
Cleared May 14, 1997
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
K970799
Alexander Mfg. Co.
Gastroenterology & Urology · 71d
Cleared Oct 21, 1996
DPS 4 DIALYZER PREPARATION SYSTEM
K955299
Seratronics, Inc.
Gastroenterology & Urology · 336d
Cleared Apr 18, 1996
DRS 4 DIALYZER REPROCESSING SYSTEM
K931336
Seratronics, Inc.
Gastroenterology & Urology · 1129d
Cleared Jan 22, 1996
FORMALIN REUSE CART
K941757
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 654d
Cleared Jan 22, 1996
RENALIN REUSE CART
K941867
Renal Scientific Service, Inc.
Gastroenterology & Urology · 644d
Cleared Nov 29, 1995
DRS 4 ND DIALYZER REPROCESSING SYSTEM
K944539
Seratronics, Inc.
Gastroenterology & Urology · 440d
Cleared Aug 29, 1994
DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
K923529
Seratronics, Inc.
Gastroenterology & Urology · 774d
Cleared Apr 09, 1992
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
K914123
Serim Research Corp.
Gastroenterology & Urology · 209d
Cleared Feb 24, 1992
DRS-4 DIALYZER REPROCESSING SYSTEM
K914580
Seratronics, Inc.
Gastroenterology & Urology · 131d
Cleared Jun 27, 1991
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
K911628
Serim Research Corp.
Gastroenterology & Urology · 77d
Cleared Jun 27, 1991
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629
Serim Research Corp.
Gastroenterology & Urology · 77d
Cleared Apr 02, 1991
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
K902227
Serim Research Corp.
Gastroenterology & Urology · 320d
Cleared Nov 27, 1990
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210
Minntech Corp.
Gastroenterology & Urology · 76d
Cleared Jul 11, 1990
SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
K900341
Serim Research Corp.
Gastroenterology & Urology · 170d
Cleared Apr 25, 1988
FRESENIUS PURISTERIL 340 (TM)
K874573
Seratronics, Inc.
Gastroenterology & Urology · 172d

About Product Code LIF - Regulatory Context