Atlas FDA

JIX

302 FDA 510(k) clearances · Product code

49 daysmedian time to decision
122 days90th percentile
302clearances measured

FDA profile

Official device name
Calibrator, Multi-Analyte Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2017: 17 · 2018: 16 · 2019: 12 · 2020: 22 · 2025: 18 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
VITROS Chemistry Products Calibrator Kit 3 (K161140)Ortho-Clinical Diagnostics, Inc.2016-05-20
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (K153365)Siemens Healthcare Diagnostics, Inc.2015-12-18
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II (K151552)Elitechgroup2015-07-08
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (K140790)Siemens Healthcare Diagnostics2015-06-15
SYSTEM CALIBRATER (K141388)Beckman Coulter Ireland, Inc.2014-07-11
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN (K133330)Roche Diagnostics2013-11-26
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II (K130765)Elitechgroup2013-04-04
DIMENSION CHEMISTRY III CALIBRATORY (K123321)Siemens Healthcare Diagnostics2013-02-15
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (K123372)Abbott Laboratories2013-01-14
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (K122398)Siemens Healthcare Diagnostics, Inc.2012-10-12
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES (K112834)Verichem Laboratories, Inc.2012-03-28
ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 (K112029)Elitechgroup2011-08-30
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) (K110394)Vital Diagnostics (Manufacturing) Ptyltd2011-06-09
SYNCHRON MULTI CALIBRATOR (K110251)Beckman Coulter, Inc.2011-05-25
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS (K103701)Siemens Healthcare Diagnostics, Inc.2011-02-18
ELECSYS ANTI-TPO CALSET (K103171)Roche Diagnostics2011-02-11
MULTICONSTITUENT CALIBRATOR (K103403)Abbott Laboratories2011-02-04
DIMENSION VISA ENZ 2 CAL (K103612)Siemens Healthcare Diagnostics, Inc.2011-01-25
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM (K101456)Roche Diagnostics2010-09-08
LOCI 8 CALIBRATOR, MODEL KC 646 (K101460)Siemens Healthcare Diagnostics2010-07-09
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A (K100778)Siemens Healthcare Diagnostics2010-05-05
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 (K093732)Siemens Healthcare Diagnostics2010-03-22
EXL ANEM CAL, MODEL RC640 (K093645)Siemens Healthcare Diagnostics2010-03-05
STA - FREE PS CALIBRATOR (K092113)Diagnostica Stago, Inc.2009-11-13
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 (K090283)Genchem, Inc.2009-06-05
EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR (K080404)Medica Corp.2009-03-13
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 (K083579)Siemens Healthcare Diagnostics2009-02-20
SENTINEL PLASMAPROTEINS CAL 3X (K081533)SENTINEL CH. SpA2008-06-25
LOCI THYROID CALIBRATOR WITH MODEL RC610 (K081103)Siemens Healthcare Diagnostics, Inc.2008-05-23
URIC ACID (AOX), SCAL, NORTROL, ABTROL (K073612)Thermofisher Scientific OY2008-05-23
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 (K080607)Roche Diagnostics Corp.2008-05-12
ABX PENTRA URINE CAL (K071779)Horiba Abx2008-03-05
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H (K072435)Dade Behring, Inc.2007-10-17
ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS (K072204)Siemens Medical Solutions Diagnostics2007-10-05
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 (K071801)Ortho-Clinical Diagnostics, Inc.2007-07-20
MODIFICATION TO SENTINEL CLIN CHEM CAL (K070971)Sentinel Ch. Srl2007-05-23
MULTI-ANALYTE CHEMISTRY CALIBRATOR (K070207)Pointe Scientific, Inc.,2007-04-13
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN (K063508)Dade Behring, Inc.2007-01-23
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL (K062035)Dade Behring, Inc.2006-10-04
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 (K062334)Dade Behring, Inc.2006-09-22
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 (K062319)Roche Diagnostics Corp.2006-09-13
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) (K062034)Dade Behring, Inc.2006-09-06
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) (K062122)Dade Behring, Inc.2006-08-25
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) (K061923)Dade Behring, Inc.2006-08-25
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 (K061838)Dade Behring, Inc.2006-08-21
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 (K061750)Dade Behring, Inc.2006-08-11
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH (K062055)Dade Behring, Inc.2006-08-07
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) (K061703)Dade Behring, Inc.2006-08-02
RANDOX LIQUID PROTEIN CALIBRATOR (K061056)Randox Laboratories, Ltd.2006-07-20
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 (K061390)Dade Behring, Inc.2006-07-05
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 (K061218)Dade Behring, Inc.2006-06-30
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III (K060940)Ortho-Clinical Diagnostics, Inc.2006-04-24
RANDOX CALIBRATION SERUM (K053153)Randox Laboratories, Ltd.2006-01-13
SENTINEL CLIN CHEM CAL (K051452)Sentinel Ch. Srl2005-10-25
LIPOPROTEIN FOR MULTIPLE ANALYTES (K051619)Bayer Healthcare, LLC2005-08-01
SENTINEL PLASMAPROTEINS CAL 3X (K051457)Sentinel Ch. Srl2005-07-25
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 (K043460)Olympus America, Inc.2005-01-31
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC (K050026)Roche Diagnostics2005-01-31
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 (K041926)Diagnostic Chemicals , Ltd.2004-11-23
MULTI-CHEM CALIBRATOR A (K042551)Wako Chemicals USA, Inc.2004-11-16
MULTI-LIPID CALIBRATOR (K042550)Wako Chemicals USA, Inc.2004-11-08
MULTI CHEM CAL B (K042549)Wako Chemicals USA, Inc.2004-11-08
MICROALBUMIN MULTI-CALIBRATOR SET (K042243)Diagnostic Chemicals , Ltd.2004-10-04
HEMOSIL CALIBRATION PLASMA (K041905)Instrumentation Laboratory CO2004-09-28
N APOLIPOPROTEIN STANDARD SERUM (K041870)Dade Behring, Inc.2004-07-27
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF (K040264)Roche Diagnostics Corp.2004-04-02
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) (K040245)Roche Diagnostics Corp.2004-03-24
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR (K032936)Stanbio Laboratory2004-03-12
BAYER SPECIFIC PROTEIN REFERENCE SERUM (K033791)Bayer Healthcare, LLC2004-02-13
ELECSYS C-PEPTIDE CALSET (K033873)Roche Diagnostics Corp.2004-02-13
OLYMPUS URINE CALIBRATOR (K033910)Cliniqa Corporation2004-01-30
BAYER SPECIAL CHEMISTRY CALIBRATORS (K033380)Bayer Diagnostics Corp.2003-12-16
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 (K032665)Olympus America, Inc.2003-11-21
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) (K033501)Roche Diagnostics Corp.2003-11-20
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE (K033061)Diamond Diagnostics, Inc.2003-11-07
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K032287)Beckman Coulter, Inc.2003-08-18
RANDOX LIQUID PROTEIN CALIBRATOR (K031608)Randox Laboratories, Ltd.2003-08-08
TOX AMMONIA CALIBRATOR (K031683)Bayer Healthcare, LLC2003-08-06
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL (K031880)Roche Diagnostics Corp.2003-07-16
LIPOPROTEIN CALIBRATOR (K031682)Bayer Healthcare, LLC2003-06-25
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR (K030804)Bayer Healthcare, LLC2003-04-10
ATAC CALIBRATOR (K030621)Elan Diagnostics2003-03-19
WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 (K024305)Wiener Laboratories Saic2003-03-18
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S (K023792)Thermo Orion2003-01-31
SETPOINT CHEMISTRY CALIBRATOR (K030169)Bayer Healthcare, LLC2003-01-31
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS (K030074)Cliniqa Corporation2003-01-21
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K023876)Ortho-Clinical Diagnostics, Inc.2002-12-10
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS (K023268)Phoenix Diagnostics, Inc.2002-11-15
RANDOX APOLIPOPROTEIN CALIBRATOR (K023158)Randox Laboratories, Ltd.2002-10-24
RAICHEM LIPID CALIBRATOR (K022767)Hemagen Diagnostics, Inc.2002-09-03
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 (K022108)Thermo Dma, Inc.2002-07-25
PACIFIC HEMOSTASIS REFERENCE EMULSION (K013397)Fisher Diagnostics2002-02-15
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE (K020129)Phoenix Diagnostics, Inc.2002-02-01
DC-UIBC-CO2-CAL, MODEL SE-153 (K013178)Diagnostic Chemicals , Ltd.2001-12-18
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER (K012987)Phoenix Diagnostics, Inc.2001-11-07
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM (K012509)Phoenix Diagnostics, Inc.2001-10-09
MODIFICATION TO N PROTEIN STANDARD SL (K012470)Dade Behring, Inc.2001-09-28
RAICHEM MULTI-ANALYTE CALIBRATOR (K012250)Hemagen Diagnostics, Inc.2001-09-24
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS (K011658)Rochdiag2001-07-31
CALIBRATOR FOR AUTOMATED SYSTEMS (K011226)Roche Diagnostics Corp.2001-06-25
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Every clearance here is in the API, with alerts when new ones post.