LIF · Class II · 21 CFR 876.5820

FDA Product Code LIF: Dialyzer Reprocessing System

Leading manufacturers include Renal Systems, Inc., Serim Research Corp. and Minntech 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 Apr 27, 2004
RENACLEAN SH DIALYZER CLEANING SYSTEM
K033505
Minntech Corp.
Gastroenterology & Urology · 174d
Cleared Aug 30, 1999
RENACLEAR DIALYZER CLEANING SYSTEM
K991851
Minntech Corp.
Gastroenterology & Urology · 90d
Cleared May 14, 1997
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
K970799
Alexander Mfg. Co.
Gastroenterology & Urology · 71d
Cleared Jan 22, 1996
FORMALIN REUSE CART
K941757
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 654d
Cleared Apr 09, 1992
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
K914123
Serim Research Corp.
Gastroenterology & Urology · 209d
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 Oct 17, 1985
COBE REN NEW-D DISPENSING KIT
K853817
Cobe Laboratories, Inc.
Gastroenterology & Urology · 35d
Cleared Jul 06, 1984
RENATRON
K842258
Renal Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 27, 1983
HPR HOME PATIENT RENATRON
K833181
Renal Systems, Inc.
Gastroenterology & Urology · 38d
Cleared Mar 31, 1983
RENALIN (TENTATIVE
K830575
Renal Systems, Inc.
Hematology · 36d
Cleared Mar 29, 1983
RENATRON DIALYZER REPROCESSING SYS
K830574
Renal Systems, Inc.
Gastroenterology & Urology · 34d
Cleared Mar 23, 1982
HYDROGEN PEROXIDE TOPICAL
K820221
Renal Systems, Inc.
Gastroenterology & Urology · 55d
Cleared Nov 06, 1981
MODEL RS 8300
K812230
Renal Systems, Inc.
Gastroenterology & Urology · 87d

About Product Code LIF - Regulatory Context