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Panels › Clinical Chemistry › Product code JIX · Class 2

Calibrator, Multi-Analyte Mixture

Regulation 862.1150

0510(k)s in 12 months (302 all time)
1recalls in 12 months (73 all time)
60recalls that name a 510(k)
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Top companies in JIX

Company510(k)sRecalls
Siemens Healthcare Diagnostics1220
Alko Diagnostic Corp.210
Dade Behring, Inc.180
Roche Diagnostics142
Ortho-Clinical Diagnostics, Inc.411
Randox Laboratories, Ltd.510
Bhp Diagnostix, Inc.110
Roche Diagnostic Systems, Inc.90
Beckman Instruments, Inc.80
Boehringer Mannheim Corp.80
Decided510(k)Device and applicantCode
May 20, 2016K161140VITROS Chemistry Products Calibrator Kit 3
Ortho-Clinical Diagnostics, Inc.
JIX
Dec 18, 2015K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
Siemens Healthcare Diagnostics, Inc.
JIX
Jul 8, 2015K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
Elitechgroup, FR
JIX
Jun 15, 2015K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
Siemens Healthcare Diagnostics
JIX
Jul 11, 2014K141388SYSTEM CALIBRATER
Beckman Coulter Ireland, Inc.
JIX
Nov 26, 2013K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
Roche Diagnostics
JIX
Apr 4, 2013K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
Elitechgroup
JIX
Feb 15, 2013K123321DIMENSION CHEMISTRY III CALIBRATORY
Siemens Healthcare Diagnostics
JIX
Jan 14, 2013K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
Abbott Laboratories
JIX
Oct 12, 2012K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
Siemens Healthcare Diagnostics, Inc.
JIX
Mar 28, 2012K112834MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
Verichem Laboratories, Inc.
JIX
Aug 30, 2011K112029ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
Elitechgroup
JIX
Jun 9, 2011K110394ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
Vital Diagnostics (Manufacturing) Ptyltd, AU
JIX
May 25, 2011K110251SYNCHRON MULTI CALIBRATOR
Beckman Coulter, Inc.
JIX
Feb 18, 2011K103701ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
Siemens Healthcare Diagnostics, Inc.
JIX
Feb 11, 2011K103171ELECSYS ANTI-TPO CALSET
Roche Diagnostics
JIX
Feb 4, 2011K103403MULTICONSTITUENT CALIBRATOR
Abbott Laboratories
JIX
Jan 25, 2011K103612DIMENSION VISA ENZ 2 CAL
Siemens Healthcare Diagnostics, Inc.
JIX
Sep 8, 2010K101456ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
Roche Diagnostics
JIX
Jul 9, 2010K101460LOCI 8 CALIBRATOR, MODEL KC 646
Siemens Healthcare Diagnostics
JIX
May 5, 2010K100778DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
Siemens Healthcare Diagnostics
JIX
Mar 22, 2010K093732ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
Siemens Healthcare Diagnostics
JIX
Mar 5, 2010K093645EXL ANEM CAL, MODEL RC640
Siemens Healthcare Diagnostics
JIX
Nov 13, 2009K092113STA - FREE PS CALIBRATOR
Diagnostica Stago, Inc.
JIX
Jun 5, 2009K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
Genchem, Inc.
JIX
Mar 13, 2009K080404EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
Medica Corp.
JIX
Feb 20, 2009K083579DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
Siemens Healthcare Diagnostics
JIX
Jun 25, 2008K081533SENTINEL PLASMAPROTEINS CAL 3X
SENTINEL CH. SpA, IT
JIX
May 23, 2008K081103LOCI THYROID CALIBRATOR WITH MODEL RC610
Siemens Healthcare Diagnostics, Inc.
JIX
May 23, 2008K073612URIC ACID (AOX), SCAL, NORTROL, ABTROL
Thermofisher Scientific OY, FI
JIX
May 12, 2008K080607CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
Roche Diagnostics Corp.
JIX
Mar 5, 2008K071779ABX PENTRA URINE CAL
Horiba Abx, FR
JIX
Oct 17, 2007K072435DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
Dade Behring, Inc.
JIX
Oct 5, 2007K072204ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
Siemens Medical Solutions Diagnostics
JIX
Jul 20, 2007K071801VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
Ortho-Clinical Diagnostics, Inc.
JIX
May 23, 2007K070971MODIFICATION TO SENTINEL CLIN CHEM CAL
Sentinel Ch. Srl, IT
JIX
Apr 13, 2007K070207MULTI-ANALYTE CHEMISTRY CALIBRATOR
Pointe Scientific, Inc.,
JIX
Jan 23, 2007K063508DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
Dade Behring, Inc.
JIX
Oct 4, 2006K062035DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL
Dade Behring, Inc.
JIX
Sep 22, 2006K062334DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
Dade Behring, Inc.
JIX
Sep 13, 2006K062319CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
Roche Diagnostics Corp.
JIX
Sep 6, 2006K062034DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
Dade Behring, Inc.
JIX
Aug 25, 2006K062122DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
Dade Behring, Inc.
JIX
Aug 25, 2006K061923DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
Dade Behring, Inc.
JIX
Aug 21, 2006K061838DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
Dade Behring, Inc.
JIX
Aug 11, 2006K061750DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
Dade Behring, Inc.
JIX
Aug 7, 2006K062055DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
Dade Behring, Inc.
JIX
Aug 2, 2006K061703DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
Dade Behring, Inc.
JIX
Jul 20, 2006K061056RANDOX LIQUID PROTEIN CALIBRATOR
Randox Laboratories, Ltd., GB
JIX
Jul 5, 2006K061390DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
Dade Behring, Inc.
JIX

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