Product code JIX— Clinical Chemistry
CALIBRATOR
- Classification name
- Calibrator, Multi-Analyte Mixture
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Total cleared
- 302
- First cleared
- Most recent
Market context for product code JIX
FDA has cleared devices under product code JIX between 1976 and 2016, filed by 106 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code JIX
Recent clearances under product code JIX
1–100 of 302- K161140 — VITROS Chemistry Products Calibrator Kit 3
- K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K141388 — SYSTEM CALIBRATER
- K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
- K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
- K123321 — DIMENSION CHEMISTRY III CALIBRATORY
- K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
- K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
- K112834 — MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
- K112029 — ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
- K110394 — ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
- K110251 — SYNCHRON MULTI CALIBRATOR
- K103701 — ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
- K103171 — ELECSYS ANTI-TPO CALSET
- K103403 — MULTICONSTITUENT CALIBRATOR
- K103612 — DIMENSION VISA ENZ 2 CAL
- K101456 — ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
- K101460 — LOCI 8 CALIBRATOR, MODEL KC 646
- K100778 — DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
- K093732 — ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
- K093645 — EXL ANEM CAL, MODEL RC640
- K092113 — STA - FREE PS CALIBRATOR
- K090283 — CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
- K080404 — EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
- K083579 — DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
- K081533 — SENTINEL PLASMAPROTEINS CAL 3X
- K073612 — URIC ACID (AOX), SCAL, NORTROL, ABTROL
- K081103 — LOCI THYROID CALIBRATOR WITH MODEL RC610
- K080607 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
- K071779 — ABX PENTRA URINE CAL
- K072435 — DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
- K072204 — ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
- K071801 — VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
- K070971 — MODIFICATION TO SENTINEL CLIN CHEM CAL
- K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR
- K063508 — DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
- K062035 — DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL
- K062334 — DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
- K062319 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
- K062034 — DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
- K061923 — DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
- K062122 — DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
- K061838 — DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
- K061750 — DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
- K062055 — DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
- K061703 — DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
- K061056 — RANDOX LIQUID PROTEIN CALIBRATOR
- K061390 — DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
- K061218 — DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
- K060940 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
- K053153 — RANDOX CALIBRATION SERUM
- K051452 — SENTINEL CLIN CHEM CAL
- K051619 — LIPOPROTEIN FOR MULTIPLE ANALYTES
- K051457 — SENTINEL PLASMAPROTEINS CAL 3X
- K043460 — OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
- K050026 — PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
- K041926 — HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
- K042551 — MULTI-CHEM CALIBRATOR A
- K042549 — MULTI CHEM CAL B
- K042550 — MULTI-LIPID CALIBRATOR
- K042243 — MICROALBUMIN MULTI-CALIBRATOR SET
- K041905 — HEMOSIL CALIBRATION PLASMA
- K041870 — N APOLIPOPROTEIN STANDARD SERUM
- K040264 — CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
- K040245 — CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
- K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
- K033791 — BAYER SPECIFIC PROTEIN REFERENCE SERUM
- K033873 — ELECSYS C-PEPTIDE CALSET
- K033910 — OLYMPUS URINE CALIBRATOR
- K033380 — BAYER SPECIAL CHEMISTRY CALIBRATORS
- K032665 — OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
- K033501 — MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
- K033061 — CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
- K032287 — MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
- K031608 — RANDOX LIQUID PROTEIN CALIBRATOR
- K031683 — TOX AMMONIA CALIBRATOR
- K031880 — AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
- K031682 — LIPOPROTEIN CALIBRATOR
- K030804 — BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
- K030621 — ATAC CALIBRATOR
- K024305 — WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
- K023792 — CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
- K030169 — SETPOINT CHEMISTRY CALIBRATOR
- K030074 — LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
- K023876 — VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
- K023268 — PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
- K023158 — RANDOX APOLIPOPROTEIN CALIBRATOR
- K022767 — RAICHEM LIPID CALIBRATOR
- K022108 — THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
- K013397 — PACIFIC HEMOSTASIS REFERENCE EMULSION
- K020129 — PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
- K013178 — DC-UIBC-CO2-CAL, MODEL SE-153
- K012987 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
- K012509 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
- K012470 — MODIFICATION TO N PROTEIN STANDARD SL
- K012250 — RAICHEM MULTI-ANALYTE CALIBRATOR
- K011658 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
- K011226 — CALIBRATOR FOR AUTOMATED SYSTEMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.