FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K010696 |
BECKMAN COULTER, INC. |
BECKMAN COULTER DNASE B CALIBRATOR |
05/10/2001 |
K994325 |
BECKMAN COULTER, INC. |
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR |
01/12/2000 |
K994169 |
BECKMAN COULTER, INC. |
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR |
02/03/2000 |
K000331 |
BECKMAN COULTER, INC. |
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR |
02/10/2000 |
K994168 |
BECKMAN COULTER, INC. |
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR |
02/03/2000 |
K983640 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS LIPID CALIBRATOR |
12/21/1998 |
K053104 |
DADE BEHRING, INC. |
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR |
12/23/2005 |
K060266 |
DADE BEHRING, INC. |
DIMENSION IRON CALIBRATOR |
03/09/2006 |
K994114 |
DADE BEHRING, INC. |
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR |
01/20/2000 |
K032697 |
DADE BEHRING, INC. |
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) |
11/07/2003 |
K061251 |
DADE BEHRING, INC. |
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR |
05/31/2006 |
K013126 |
DADE BEHRING, INC. |
N LP(A) STANDARD SY |
11/09/2001 |
K030546 |
DENKA SEIKEN CO., LTD. |
CRP (II) CALIBRATORS |
06/02/2003 |
K032608 |
GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB |
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER |
10/21/2003 |
K030964 |
INSTRUMENTATION LABORATORY CO. |
CALIBRATION PLASMA LMW HEPARIN |
06/06/2003 |
K022901 |
ORTHO-CLINICAL DIAGNOSTICS |
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS |
09/27/2002 |
K994145 |
Ortho-Clinical Diagnostics, Inc. |
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS |
12/22/1999 |
K032296 |
Ortho-Clinical Diagnostics, Inc. |
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS |
08/13/2003 |
K964475 |
OXARC, INC. |
CLINICAL BLOOD GAS MIXTURES |
12/06/1996 |
K970933 |
POINTE SCIENTIFIC, INC. |
AUTO HDL CHOLESTEROL CALIBRATOR |
05/23/1997 |
K122126 |
RANDOX LABORATORIES LIMITED |
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR |
08/14/2012 |
K022682 |
RANDOX LABORATORIES, LTD. |
RANDOX C-REACTIVE PROTEIN CALIBRATOR |
11/05/2002 |
K011568 |
RANDOX LABORATORIES, LTD. |
RANDOX LIPOPROTEIN |
09/28/2001 |
K003969 |
ROCHE DIAGNOSTICS CORP. |
ELECSYS CA 125 II CALSET |
01/12/2001 |
K002353 |
ROCHE DIAGNOSTICS CORP. |
ELECSYS CA 15-3 CALCHECK |
08/10/2000 |
K002760 |
ROCHE DIAGNOSTICS CORP. |
ELECSYS DHEA-S CALSET |
10/05/2000 |
K003941 |
ROCHE DIAGNOSTICS CORP. |
ELECSYS HCG STAT CLASET II |
01/25/2001 |
K001906 |
ROCHE DIAGNOSTICS CORP. |
ELECSYS INSULIN CALSET |
07/13/2000 |
K012878 |
THERMO DMA, INC. |
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 |
10/16/2001 |
K001004 |
WAKO CHEMICALS, USA, INC. |
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR |
06/01/2000 |
K030320 |
WAKO CHEMICALS, USA, INC. |
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET |
04/11/2003 |
K993219 |
WAKO CHEMICALS, USA, INC. |
WAKO BILIRUBIN CALIBRATOR |
11/09/1999 |
K963847 |
WAKO CHEMICALS, USA, INC. |
WAKO DIRECT HDL-C |
12/24/1996 |
K001005 |
WAKO CHEMICALS, USA, INC. |
WAKO HDL-C/LDL-C CALIBRATOR |
06/01/2000 |
K001002 |
WAKO CHEMICALS, USA, INC. |
WAKO LIPASE CALIBRATOR |
05/24/2000 |