FDA 510(k) Applications for Medical Device Product Code "JIS"
(Calibrator, Primary)

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


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