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 |