LIF — Dialyzer Reprocessing System

Class 2

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (57)

Device Name	Manufacturer	K-Number	Decision Date
CLEARFLUX DIALYZER REPROCESSING SYSTEM	Novaflux Technologies	K091360	2010-11-03
ASSIST HEADER CLEANER	Alcavis International, Inc.	K043126	2005-02-03
STERICHEK GLUTARALDEHYDE REAGENT STRIPS	Hach Company	K040660	2004-11-15
RENACLEAN SH DIALYZER CLEANING SYSTEM	Minntech Corp.	K033505	2004-04-27
MAKY 21.1 DIALYZER REPROCESSING SYSTEM	Hdc Maquinolas, LLC	K024076	2003-09-26
ARM AUTOMATIC REPROCESSING MACHINE	Alcavis International Incorporated	K013713	2002-07-15
AMUKIN D	Amuchina Intl., Inc.	K992016	2000-01-10
RENACLEAR DIALYZER CLEANING SYSTEM	Minntech Corp.	K991851	1999-08-30
POTENCY TEST STRIPS, INDICATOR TEST STRIPS	Reprocessing Products Corp	K974426	1999-02-10
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS	Environmental Test Systems, Inc.	K974798	1998-03-20
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)	Alexander Mfg. Co.	K970799	1997-05-14
DPS 4 DIALYZER PREPARATION SYSTEM	Seratronics, Inc.	K955299	1996-10-21
DRS 4 DIALYZER REPROCESSING SYSTEM	Seratronics, Inc.	K931336	1996-04-18
FORMALIN REUSE CART	National Medical Care, Medical Products Div., Inc.	K941757	1996-01-22
RENALIN REUSE CART	Renal Scientific Service, Inc.	K941867	1996-01-22
DRS 4 ND DIALYZER REPROCESSING SYSTEM	Seratronics, Inc.	K944539	1995-11-29
DIALYZER REPROCESSING SYSTEM	G.E.M. Water Systems	K944492	1995-08-28
DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES	Seratronics, Inc.	K923529	1994-08-29
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS	Serim Research Corp.	K914123	1992-04-09
DRS-4 DIALYZER REPROCESSING SYSTEM	Seratronics, Inc.	K914580	1992-02-24

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