Dialyzer Reprocessing System

FDA product code LIF · 57 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5820
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1981-05-08 – 2010-11-03

LIF 2010-11-03

CLEARFLUX DIALYZER REPROCESSING SYSTEM

Applicant Novaflux Technologies

K number K091360

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LIF 2005-02-03

ASSIST HEADER CLEANER

Applicant Alcavis International, Inc.

K number K043126

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LIF 2004-11-15

STERICHEK GLUTARALDEHYDE REAGENT STRIPS

Applicant Hach Company

K number K040660

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LIF 2004-04-27

RENACLEAN SH DIALYZER CLEANING SYSTEM

Applicant Minntech Corp.

K number K033505

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LIF 2003-09-26

MAKY 21.1 DIALYZER REPROCESSING SYSTEM

Applicant Hdc Maquinolas, LLC

K number K024076

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LIF 2002-07-15

ARM AUTOMATIC REPROCESSING MACHINE

Applicant Alcavis International Incorporated

K number K013713

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LIF 2000-01-10

AMUKIN D

Applicant Amuchina Intl., Inc.

K number K992016

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LIF 1999-08-30

RENACLEAR DIALYZER CLEANING SYSTEM

Applicant Minntech Corp.

K number K991851

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LIF 1999-02-10

POTENCY TEST STRIPS, INDICATOR TEST STRIPS

Applicant Reprocessing Products Corp

K number K974426

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LIF 1998-03-20

STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS

Applicant Environmental Test Systems, Inc.

K number K974798

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LIF 1997-05-14

ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)

Applicant Alexander Mfg. Co.

K number K970799

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LIF 1996-10-21

DPS 4 DIALYZER PREPARATION SYSTEM

Applicant Seratronics, Inc.

K number K955299

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LIF 1996-04-18

DRS 4 DIALYZER REPROCESSING SYSTEM

Applicant Seratronics, Inc.

K number K931336

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LIF 1996-01-22

RENALIN REUSE CART

Applicant Renal Scientific Service, Inc.

K number K941867

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LIF 1996-01-22

FORMALIN REUSE CART

Applicant National Medical Care, Medical Products Div., Inc.

K number K941757

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LIF 1995-11-29

DRS 4 ND DIALYZER REPROCESSING SYSTEM

Applicant Seratronics, Inc.

K number K944539

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LIF 1995-08-28

DIALYZER REPROCESSING SYSTEM

Applicant G.E.M. Water Systems

K number K944492

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LIF 1994-08-29

DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES

Applicant Seratronics, Inc.

K number K923529

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LIF 1992-04-09

SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS

Applicant Serim Research Corp.

K number K914123

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LIF 1992-02-24

DRS-4 DIALYZER REPROCESSING SYSTEM

Applicant Seratronics, Inc.

K number K914580

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LIF 1991-06-27

SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)

Applicant Serim Research Corp.

K number K911629

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LIF 1991-06-27

SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)

Applicant Serim Research Corp.

K number K911628

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LIF 1991-04-09

FORMASURE TEST REAGENT

Applicant Di-Chem, Inc.

K number K905217

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LIF 1991-04-02

SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT

Applicant Serim Research Corp.

K number K902227

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LIF 1990-11-27

RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330

Applicant Minntech Corp.

K number K904210

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LIF 1990-07-11

SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT

Applicant Serim Research Corp.

K number K900341

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LIF 1988-12-27

TRANSLUMINAL ENDARTERECTOMY DEVICE

Applicant Thomas J. Fogarty, M.D.

K number K884154

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LIF 1988-04-25

FRESENIUS PURISTERIL 340 (TM)

Applicant Seratronics, Inc.

K number K874573

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LIF 1987-10-23

ADR-22 AUTOMATIC DIALYZER REPROCESSOR

Applicant Biodynamics Corp.

K number K874034

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LIF 1987-04-10

HR-3000 REUSE ADAPTOR

Applicant Colorado Medical, Inc.

K number K870689

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LIF 1987-04-10

MODIFIED HR-3000 REUSE ADAPTOR

Applicant Colorado Medical, Inc.

K number K870471

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LIF 1986-04-07

DRS-4 DIALYZER REPROCESSING SYSTEM

Applicant Seratronics, Inc.

K number K860674

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LIF 1986-03-14

ULTRAMAX III, DIALYZER REPROCESSING DEVICE

Applicant Medicorp, Inc.

K number K860026

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LIF 1985-10-17

COBE REN NEW-D DISPENSING KIT

Applicant Cobe Laboratories, Inc.

K number K853817

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LIF 1985-09-06

RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS

Applicant Alcide Corp.

K number K853413

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LIF 1985-07-29

RINSE MACHINE KR-4 KIDNEY RINSE-4

Applicant Medical Technologies International, Inc.

K number K850799

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LIF 1985-03-20

FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G

Applicant Computer Dialysis Systems, Inc.

K number K850127

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LIF 1984-10-04

WAREXIN RECOMMENDED ALTERNATIVE DIALYZ

Applicant Mesa Medical, Inc.

K number K843520

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LIF 1984-07-16

ADAPTOR HR-3000 REUSE

Applicant Colorado Medical, Inc.

K number K841153

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LIF 1984-07-06

RENATRON

Applicant Renal Systems, Inc.

K number K842258

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LIF 1984-06-27

FORMA-FAS-TEST

Applicant Chemical Detection & Experimentation

K number K833128

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LIF 1984-06-25

ULTRAMAX

Applicant Medicorp, Inc.

K number K832705

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LIF 1984-03-23

ECHO MM1000

Applicant Mesa Medical, Inc.

K number K834447

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LIF 1983-10-27

HPR HOME PATIENT RENATRON

Applicant Renal Systems, Inc.

K number K833181

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LIF 1983-10-14

DIALYZER PREPARATION SYS DPS-4

Applicant Seratronics, Inc.

K number K832230

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LIF 1983-08-08

COMPUDIAL/KP-1

Applicant Computer Dialysis Systems, Inc.

K number K831132

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LIF 1983-06-30

SPORIDIDIN-D COLD STERILIZING/SOLUTION

Applicant Sporicidin Intl.

K number K830722

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LIF 1983-05-27

AHR-3000 RE-USE ADAPTOR

Applicant Colorado Medical, Inc.

K number K830190

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LIF 1983-03-31

RENALIN (TENTATIVE

Applicant Renal Systems, Inc.

K number K830575

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LIF 1983-03-29

RENATRON DIALYZER REPROCESSING SYS

Applicant Renal Systems, Inc.

K number K830574

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LIF 1982-10-18

DIALYZER REPROCESSING SYSTEM DRS-4

Applicant Seratronics, Inc.

K number K821863

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LIF 1982-06-23

ECHO, MODEL MM-1000

Applicant Mesa Medical, Inc.

K number K821383

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LIF 1982-04-29

AUTOMATIC DIALYZER REPROCESSOR #ADR-22

Applicant Texas Medical Devices, Inc.

K number K820695

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LIF 1982-03-23

HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE

Applicant Renal Systems, Inc.

K number K820221

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LIF 1982-03-23

COMPUDIAL/KP-1

Applicant Computer Dialysis Systems, Inc.

K number K813107

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LIF 1981-11-06

MODEL RS 8300

Applicant Renal Systems, Inc.

K number K812230

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LIF 1981-05-08

LIXIVITRON

Applicant United Medical

K number K802828

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