FDA 510(k) Applications for Medical Device Product Code "LIF"
(Dialyzer Reprocessing System)

FDA 510(k) Number Applicant Device Name Decision Date
K013713 ALCAVIS INTERNATIONAL INCORPORATED ARM AUTOMATIC REPROCESSING MACHINE 07/15/2002
K043126 ALCAVIS INTERNATIONAL, INC. ASSIST HEADER CLEANER 02/03/2005
K970799 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) 05/14/1997
K992016 AMUCHINA INTL., INC. AMUKIN D 01/10/2000
K974798 ENVIRONMENTAL TEST SYSTEMS, INC. STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS 03/20/1998
K040660 HACH COMPANY STERICHEK GLUTARALDEHYDE REAGENT STRIPS 11/15/2004
K024076 HDC MAQUINOLAS, LLC MAKY 21.1 DIALYZER REPROCESSING SYSTEM 09/26/2003
K033505 MINNTECH CORP. RENACLEAN SH DIALYZER CLEANING SYSTEM 04/27/2004
K991851 MINNTECH CORP. RENACLEAR DIALYZER CLEANING SYSTEM 08/30/1999
K941757 NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. FORMALIN REUSE CART 01/22/1996
K091360 NOVAFLUX TECHNOLOGIES CLEARFLUX DIALYZER REPROCESSING SYSTEM 11/03/2010
K941867 RENAL SCIENTIFIC SERVICE, INC. RENALIN REUSE CART 01/22/1996
K974426 REPROCESSING PRODUCTS CORP. POTENCY TEST STRIPS, INDICATOR TEST STRIPS 02/10/1999
K955299 SERATRONICS, INC. DPS 4 DIALYZER PREPARATION SYSTEM 10/21/1996
K931336 SERATRONICS, INC. DRS 4 DIALYZER REPROCESSING SYSTEM 04/18/1996


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