FDA 510(k) Applications for Medical Device Product Code "JIX"
(Calibrator, Multi-Analyte Mixture)

FDA 510(k) Number Applicant Device Name Decision Date
K123372 ABBOTT LABORATORIES ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR 01/14/2013
K981706 ABBOTT LABORATORIES AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 07/09/1998
K103403 ABBOTT LABORATORIES MULTICONSTITUENT CALIBRATOR 02/04/2011
K001484 ALKO DIAGNOSTIC CORP. CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 06/19/2000
K982501 ALKO DIAGNOSTIC CORP. ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 09/01/1998
K960085 ALKO DIAGNOSTIC CORP. ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS 03/11/1996
K970921 ALKO DIAGNOSTIC CORP. STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) 04/08/1997
K033380 BAYER DIAGNOSTICS CORP. BAYER SPECIAL CHEMISTRY CALIBRATORS 12/16/2003
K030804 BAYER HEALTHCARE, LLC BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR 04/10/2003
K033791 BAYER HEALTHCARE, LLC BAYER SPECIFIC PROTEIN REFERENCE SERUM 02/13/2004
K031682 BAYER HEALTHCARE, LLC LIPOPROTEIN CALIBRATOR 06/25/2003
K051619 BAYER HEALTHCARE, LLC LIPOPROTEIN FOR MULTIPLE ANALYTES 08/01/2005
K030169 BAYER HEALTHCARE, LLC SETPOINT CHEMISTRY CALIBRATOR 01/31/2003
K031683 BAYER HEALTHCARE, LLC TOX AMMONIA CALIBRATOR 08/06/2003
K141388 BECKMAN COULTER IRELAND INC SYSTEM CALIBRATER 07/11/2014
K032287 BECKMAN COULTER, INC. MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 08/18/2003
K110251 BECKMAN COULTER, INC. SYNCHRON MULTI CALIBRATOR 05/25/2011
K984014 BECKMAN COULTER, INC. SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 12/23/1998
K973932 BECKMAN INSTRUMENTS, INC. BECKMAN CALIBRATOR 2 (CAL2) 12/15/1997
K973928 BECKMAN INSTRUMENTS, INC. BECKMAN URINE PROTEIN CALIBRATOR (UCAL) 12/01/1997
K971333 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD 05/23/1997
K971283 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS CAL 5 PLUS 06/03/1997
K962406 BEHRING DIAGNOSTICS, INC. N CRP STANDARD SY 07/16/1996
K962410 BEHRING DIAGNOSTICS, INC. N PROTEIN STANDARD PY 07/16/1996
K964062 BEHRING DIAGNOSTICS, INC. N PROTEIN STRANDARD SL 11/21/1996
K964527 BEHRING DIAGNOSTICS, INC. N RHEUMATOLOGY STANDARD SL 01/15/1997
K974825 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS 01/30/1998
K962269 BOEHRINGER MANNHEIM CORP. CEDIA CARDIAC TDM MULTI-CALS 10/29/1996
K961659 BOEHRINGER MANNHEIM CORP. CEDIA CORE TDM MULTI-CAL 06/13/1996
K964829 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK FSH 12/16/1996
K984425 BOEHRINGER MANNHEIM CORP. MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR 01/20/1999
K983469 BOEHRINGER MANNHEIM CORP. PRECISET SERUM PROTEINS CALIBRATOR 11/25/1998
K962629 CASCO STANDARDS DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR 09/13/1996
K981436 CASCO STANDARDS DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 04/24/1998
K030074 CLINIQA CORPORATION LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS 01/21/2003
K033910 CLINIQA CORPORATION OLYMPUS URINE CALIBRATOR 01/30/2004
K011035 DADE BEHRING, INC. DIMENSION DRUG CALIBRATOR, MODEL DC22B 06/14/2001
K061838 DADE BEHRING, INC. DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 08/21/2006
K061703 DADE BEHRING, INC. DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) 08/02/2006
K062334 DADE BEHRING, INC. DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 09/22/2006
K061923 DADE BEHRING, INC. DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) 08/25/2006
K063508 DADE BEHRING, INC. DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN 01/23/2007
K062055 DADE BEHRING, INC. DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH 08/07/2006
K072435 DADE BEHRING, INC. DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H 10/17/2007
K062035 DADE BEHRING, INC. DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL 10/04/2006
K062122 DADE BEHRING, INC. DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) 08/25/2006
K061218 DADE BEHRING, INC. DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 06/30/2006
K062034 DADE BEHRING, INC. DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) 09/06/2006
K061390 DADE BEHRING, INC. DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 07/05/2006
K061750 DADE BEHRING, INC. DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 08/11/2006
K991181 DADE BEHRING, INC. MODIFICATION OF N PROTEIN STANDARD SL 06/01/1999
K012470 DADE BEHRING, INC. MODIFICATION TO N PROTEIN STANDARD SL 09/28/2001
K041870 DADE BEHRING, INC. N APOLIPOPROTEIN STANDARD SERUM 07/27/2004
K002804 DADE BEHRING, INC. N PROTEIN STANDARD SL 10/05/2000
K960103 DADE INTL., INC. DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS 04/26/1996
K993098 DATA MEDICAL ASSOCIATES, INC. HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 10/08/1999
K013178 DIAGNOSTIC CHEMICALS LTD. DC-UIBC-CO2-CAL, MODEL SE-153 12/18/2001
K041926 DIAGNOSTIC CHEMICALS LTD. HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 11/23/2004
K042243 DIAGNOSTIC CHEMICALS LTD. MICROALBUMIN MULTI-CALIBRATOR SET 10/04/2004
K092113 DIAGNOSTICA STAGO, INC. STA - FREE PS CALIBRATOR 11/13/2009
K033061 DIAMOND DIAGNOSTICS, INC. CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE 11/07/2003
K030621 ELAN DIAGNOSTICS ATAC CALIBRATOR 03/19/2003
K992845 ELAN HOLDINGS, INC. HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT 10/18/1999
K151552 ELITechGroup ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II 07/08/2015
K112029 ELITECHGROUP ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 08/30/2011
K130765 ELITECHGROUP ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II 04/04/2013
K013397 FISHER DIAGNOSTICS PACIFIC HEMOSTASIS REFERENCE EMULSION 02/15/2002
K090283 GENCHEM, INC. CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 06/05/2009
K022767 HEMAGEN DIAGNOSTICS, INC. RAICHEM LIPID CALIBRATOR 09/03/2002
K012250 HEMAGEN DIAGNOSTICS, INC. RAICHEM MULTI-ANALYTE CALIBRATOR 09/24/2001
K071779 HORIBA ABX ABX PENTRA URINE CAL 03/05/2008
K041905 INSTRUMENTATION LABORATORY CO. HEMOSIL CALIBRATION PLASMA 09/28/2004
K993606 KAMIYA BIOMEDICAL CO. K-ASSAY APO A1/B CALIBRATOR SET 11/26/1999
K991166 KAMIYA BIOMEDICAL CO. K-ASSAY MICROALBUMIN CALIBRATOR SET 06/10/1999
K993853 KAMIYA BIOMEDICAL CO. K-ASSAY MULTI-ANALYTE CALIBRATOR 12/27/1999
K080404 MEDICA CORP. EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR 03/13/2009
K032665 OLYMPUS AMERICA, INC. OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 11/21/2003
K043460 OLYMPUS AMERICA, INC. OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 01/31/2005
K981305 OLYMPUS AMERICA, INC. OLYMPUS SERUM PROTEIN MULTICALIBRATOR 05/07/1998
K992086 OLYMPUS AMERICA, INC. OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 08/19/1999
K161140 ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS Chemistry Products Calibrator Kit 3 05/20/2016
K060940 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III 04/24/2006
K071801 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 07/20/2007
K023876 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 12/10/2002
K012509 PHOENIX DIAGNOSTICS, INC. PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM 10/09/2001
K012987 PHOENIX DIAGNOSTICS, INC. PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER 11/07/2001
K020129 PHOENIX DIAGNOSTICS, INC. PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE 02/01/2002
K023268 PHOENIX DIAGNOSTICS, INC. PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS 11/15/2002
K070207 POINTE SCIENTIFIC, INC. MULTI-ANALYTE CHEMISTRY CALIBRATOR 04/13/2007
K982767 RAICHEM RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR 09/21/1998
K955489 RANDOX LABORATORIES, LTD. CALIBRATION SERUM LEVEL 1 & 2 06/21/1996
K023158 RANDOX LABORATORIES, LTD. RANDOX APOLIPOPROTEIN CALIBRATOR 10/24/2002
K053153 RANDOX LABORATORIES, LTD. RANDOX CALIBRATION SERUM 01/13/2006
K061056 RANDOX LABORATORIES, LTD. RANDOX LIQUID PROTEIN CALIBRATOR 07/20/2006
K031608 RANDOX LABORATORIES, LTD. RANDOX LIQUID PROTEIN CALIBRATOR 08/08/2003
K011658 ROCHDIAG CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS 07/31/2001
K133330 Roche Diagnostics C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN 11/26/2013
K103171 Roche Diagnostics ELECSYS ANTI-TPO CALSET 02/11/2011
K050026 Roche Diagnostics PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC 01/31/2005
K101456 Roche Diagnostics ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM 09/08/2010
K031880 ROCHE DIAGNOSTICS CORP. AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL 07/16/2003
K011226 ROCHE DIAGNOSTICS CORP. CALIBRATOR FOR AUTOMATED SYSTEMS 06/25/2001
K990460 ROCHE DIAGNOSTICS CORP. CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) 03/22/1999
K080607 ROCHE DIAGNOSTICS CORP. CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 05/12/2008
K062319 ROCHE DIAGNOSTICS CORP. CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 09/13/2006
K040245 ROCHE DIAGNOSTICS CORP. CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) 03/24/2004
K040264 ROCHE DIAGNOSTICS CORP. CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF 04/02/2004
K033873 ROCHE DIAGNOSTICS CORP. ELECSYS C-PEPTIDE CALSET 02/13/2004
K000576 ROCHE DIAGNOSTICS CORP. ELECSYS CORTISOL CALCHECK 03/21/2000
K033501 ROCHE DIAGNOSTICS CORP. MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) 11/20/2003
K081533 SENTINEL CH. SpA SENTINEL PLASMAPROTEINS CAL 3X 06/25/2008
K070971 SENTINEL CH. SRL MODIFICATION TO SENTINEL CLIN CHEM CAL 05/23/2007
K051452 SENTINEL CH. SRL SENTINEL CLIN CHEM CAL 10/25/2005
K051457 SENTINEL CH. SRL SENTINEL PLASMAPROTEINS CAL 3X 07/25/2005
K093732 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 03/22/2010
K123321 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION CHEMISTRY III CALIBRATORY 02/15/2013
K100778 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A 05/05/2010
K140790 SIEMENS HEALTHCARE DIAGNOSTICS Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) 06/15/2015
K083579 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 02/20/2009
K093645 SIEMENS HEALTHCARE DIAGNOSTICS EXL ANEM CAL, MODEL RC640 03/05/2010
K101460 SIEMENS HEALTHCARE DIAGNOSTICS LOCI 8 CALIBRATOR, MODEL KC 646 07/09/2010
K103612 SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISA ENZ 2 CAL 01/25/2011
K081103 Siemens Healthcare Diagnostics Inc. LOCI THYROID CALIBRATOR WITH MODEL RC610 05/23/2008
K122398 Siemens Healthcare Diagnostics Inc. RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS 10/12/2012
K153365 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator 12/18/2015
K103701 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS 02/18/2011
K072204 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS 10/05/2007
K963533 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 10/29/1996
K963543 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 10/30/1996
K010652 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 03/30/2001
K032936 STANBIO LABORATORY DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR 03/12/2004
K010030 SYNERGENT BIOCHEM INC.-CLINICAL CONTROLS DIV. LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR 02/14/2001
K981795 THERMO BIOANALYSIS CORP. CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO 06/12/1998
K022108 THERMO DMA, INC. THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 07/25/2002
K073612 THERMO FISHER SCIENTIFIC OY URIC ACID (AOX), SCAL, NORTROL, ABTROL 05/23/2008
K023792 THERMO ORION CALIBRATION PACK, MODELS A9100-101S AND A9100-103S 01/31/2003
K972333 VERICHEM LABORATORIES, INC. AMMONIA/IRON STANDARD KIT 07/23/1997
K973345 VERICHEM LABORATORIES, INC. MATRIX PLUS MULTI-CALIBRATOR KIT 10/29/1997
K974290 VERICHEM LABORATORIES, INC. MICROPROTEIN STANDARD KIT 12/19/1997
K112834 VERICHEM LABORATORIES, INC. MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES 03/28/2012
K110394 VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) 06/09/2011
K042549 WAKO CHEMICALS, USA, INC. MULTI CHEM CAL B 11/08/2004
K042551 WAKO CHEMICALS, USA, INC. MULTI-CHEM CALIBRATOR A 11/16/2004
K042550 WAKO CHEMICALS, USA, INC. MULTI-LIPID CALIBRATOR 11/08/2004
K024305 WIENER LABORATORIES S.A.I.C. WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 03/18/2003


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