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
57 devices
25–48 of 57
Cleared Oct 23, 1987
ADR-22 AUTOMATIC DIALYZER REPROCESSOR
K874034
Biodynamics Corp.
Gastroenterology & Urology · 18d
Cleared Apr 07, 1986
DRS-4 DIALYZER REPROCESSING SYSTEM
K860674
Seratronics, Inc.
Gastroenterology & Urology · 42d
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 Oct 14, 1983
DIALYZER PREPARATION SYS DPS-4
K832230
Seratronics, Inc.
Gastroenterology & Urology · 95d
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 Oct 18, 1982
DIALYZER REPROCESSING SYSTEM DRS-4
K821863
Seratronics, Inc.
Gastroenterology & Urology · 116d
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