FDA Product Code
FDA Product Code JIX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1150
510(k) Clearances — 302 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | 2016-05-20 | Abbreviated | PDF ↗ |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | 2015-12-18 | Traditional | PDF ↗ |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | Elitechgroup | 2015-07-08 | Abbreviated | PDF ↗ |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | Siemens Healthcare Diagnostics | 2015-06-15 | Traditional | PDF ↗ |
| K141388 | SYSTEM CALIBRATER | Beckman Coulter Ireland, Inc. | 2014-07-11 | Abbreviated | PDF ↗ |
| K133330 | C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN | Roche Diagnostics | 2013-11-26 | Special | PDF ↗ |
| K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | Elitechgroup | 2013-04-04 | Abbreviated | PDF ↗ |
| K123321 | DIMENSION CHEMISTRY III CALIBRATORY | Siemens Healthcare Diagnostics | 2013-02-15 | Traditional | PDF ↗ |
| K123372 | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR | Abbott Laboratories | 2013-01-14 | Traditional | PDF ↗ |
| K122398 | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2012-10-12 | Traditional | PDF ↗ |
| K112834 | MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES | Verichem Laboratories, Inc. | 2012-03-28 | Abbreviated | PDF ↗ |
| K112029 | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 | Elitechgroup | 2011-08-30 | Abbreviated | PDF ↗ |
| K110394 | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-09 | Abbreviated | PDF ↗ |
| K110251 | SYNCHRON MULTI CALIBRATOR | Beckman Coulter, Inc. | 2011-05-25 | Traditional | PDF ↗ |
| K103701 | ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2011-02-18 | Abbreviated | PDF ↗ |
| K103171 | ELECSYS ANTI-TPO CALSET | Roche Diagnostics | 2011-02-11 | Traditional | PDF ↗ |
| K103403 | MULTICONSTITUENT CALIBRATOR | Abbott Laboratories | 2011-02-04 | Traditional | PDF ↗ |
| K103612 | DIMENSION VISA ENZ 2 CAL | Siemens Healthcare Diagnostics, Inc. | 2011-01-25 | Traditional | PDF ↗ |
| K101456 | ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM | Roche Diagnostics | 2010-09-08 | Special | PDF ↗ |
| K101460 | LOCI 8 CALIBRATOR, MODEL KC 646 | Siemens Healthcare Diagnostics | 2010-07-09 | Abbreviated | PDF ↗ |
| K100778 | DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A | Siemens Healthcare Diagnostics | 2010-05-05 | Traditional | PDF ↗ |
| K093732 | ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 | Siemens Healthcare Diagnostics | 2010-03-22 | Abbreviated | PDF ↗ |
| K093645 | EXL ANEM CAL, MODEL RC640 | Siemens Healthcare Diagnostics | 2010-03-05 | Traditional | PDF ↗ |
| K092113 | STA - FREE PS CALIBRATOR | Diagnostica Stago, Inc. | 2009-11-13 | Traditional | PDF ↗ |
| K090283 | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 | Genchem, Inc. | 2009-06-05 | Abbreviated | PDF ↗ |
| K080404 | EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR | Medica Corp. | 2009-03-13 | Traditional | PDF ↗ |
| K083579 | DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 | Siemens Healthcare Diagnostics | 2009-02-20 | Abbreviated | PDF ↗ |
| K081533 | SENTINEL PLASMAPROTEINS CAL 3X | SENTINEL CH. SpA | 2008-06-25 | Traditional | PDF ↗ |
| K073612 | URIC ACID (AOX), SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-05-23 | Traditional | PDF ↗ |
| K081103 | LOCI THYROID CALIBRATOR WITH MODEL RC610 | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 | Traditional | PDF ↗ |
| K080607 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 | Roche Diagnostics Corp. | 2008-05-12 | Traditional | PDF ↗ |
| K071779 | ABX PENTRA URINE CAL | Horiba Abx | 2008-03-05 | Abbreviated | PDF ↗ |
| K072435 | DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H | Dade Behring, Inc. | 2007-10-17 | Traditional | PDF ↗ |
| K072204 | ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS | Siemens Medical Solutions Diagnostics | 2007-10-05 | Abbreviated | PDF ↗ |
| K071801 | VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 | Ortho-Clinical Diagnostics, Inc. | 2007-07-20 | Special | PDF ↗ |
| K070971 | MODIFICATION TO SENTINEL CLIN CHEM CAL | Sentinel Ch. Srl | 2007-05-23 | Traditional | PDF ↗ |
| K070207 | MULTI-ANALYTE CHEMISTRY CALIBRATOR | Pointe Scientific, Inc., | 2007-04-13 | Abbreviated | PDF ↗ |
| K063508 | DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN | Dade Behring, Inc. | 2007-01-23 | Traditional | PDF ↗ |
| K062035 | DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL | Dade Behring, Inc. | 2006-10-04 | Traditional | PDF ↗ |
| K062334 | DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 | Dade Behring, Inc. | 2006-09-22 | Traditional | PDF ↗ |
| K062319 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 | Roche Diagnostics Corp. | 2006-09-13 | Traditional | PDF ↗ |
| K062034 | DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) | Dade Behring, Inc. | 2006-09-06 | Traditional | PDF ↗ |
| K062122 | DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) | Dade Behring, Inc. | 2006-08-25 | Traditional | PDF ↗ |
| K061923 | DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) | Dade Behring, Inc. | 2006-08-25 | Traditional | PDF ↗ |
| K061838 | DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 | Dade Behring, Inc. | 2006-08-21 | Traditional | PDF ↗ |
| K061750 | DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 | Dade Behring, Inc. | 2006-08-11 | Traditional | PDF ↗ |
| K062055 | DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH | Dade Behring, Inc. | 2006-08-07 | Traditional | PDF ↗ |
| K061703 | DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) | Dade Behring, Inc. | 2006-08-02 | Traditional | PDF ↗ |
| K061056 | RANDOX LIQUID PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2006-07-20 | Traditional | PDF ↗ |
| K061390 | DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 | Dade Behring, Inc. | 2006-07-05 | Traditional | PDF ↗ |
| K061218 | DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 | Dade Behring, Inc. | 2006-06-30 | Traditional | PDF ↗ |
| K060940 | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III | Ortho-Clinical Diagnostics, Inc. | 2006-04-24 | Traditional | PDF ↗ |
| K053153 | RANDOX CALIBRATION SERUM | Randox Laboratories, Ltd. | 2006-01-13 | Traditional | PDF ↗ |
| K051452 | SENTINEL CLIN CHEM CAL | Sentinel Ch. Srl | 2005-10-25 | Abbreviated | PDF ↗ |
| K051619 | LIPOPROTEIN FOR MULTIPLE ANALYTES | Bayer Healthcare, LLC | 2005-08-01 | Abbreviated | PDF ↗ |
| K051457 | SENTINEL PLASMAPROTEINS CAL 3X | Sentinel Ch. Srl | 2005-07-25 | Abbreviated | PDF ↗ |
| K050026 | PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC | Roche Diagnostics | 2005-01-31 | Special | PDF ↗ |
| K043460 | OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 | Olympus America, Inc. | 2005-01-31 | Abbreviated | PDF ↗ |
| K041926 | HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 | Diagnostic Chemicals , Ltd. | 2004-11-23 | Traditional | PDF ↗ |
| K042551 | MULTI-CHEM CALIBRATOR A | Wako Chemicals USA, Inc. | 2004-11-16 | Traditional | PDF ↗ |
| K042550 | MULTI-LIPID CALIBRATOR | Wako Chemicals USA, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K042549 | MULTI CHEM CAL B | Wako Chemicals USA, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K042243 | MICROALBUMIN MULTI-CALIBRATOR SET | Diagnostic Chemicals , Ltd. | 2004-10-04 | Traditional | PDF ↗ |
| K041905 | HEMOSIL CALIBRATION PLASMA | Instrumentation Laboratory CO | 2004-09-28 | Traditional | PDF ↗ |
| K041870 | N APOLIPOPROTEIN STANDARD SERUM | Dade Behring, Inc. | 2004-07-27 | Traditional | PDF ↗ |
| K040264 | CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF | Roche Diagnostics Corp. | 2004-04-02 | Traditional | PDF ↗ |
| K040245 | CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) | Roche Diagnostics Corp. | 2004-03-24 | Traditional | PDF ↗ |
| K032936 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR | Stanbio Laboratory | 2004-03-12 | Traditional | PDF ↗ |
| K033791 | BAYER SPECIFIC PROTEIN REFERENCE SERUM | Bayer Healthcare, LLC | 2004-02-13 | Abbreviated | PDF ↗ |
| K033873 | ELECSYS C-PEPTIDE CALSET | Roche Diagnostics Corp. | 2004-02-13 | Traditional | PDF ↗ |
| K033910 | OLYMPUS URINE CALIBRATOR | Cliniqa Corporation | 2004-01-30 | Traditional | PDF ↗ |
| K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS | Bayer Diagnostics Corp. | 2003-12-16 | Abbreviated | PDF ↗ |
| K032665 | OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 | Olympus America, Inc. | 2003-11-21 | Abbreviated | PDF ↗ |
| K033501 | MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) | Roche Diagnostics Corp. | 2003-11-20 | Special | PDF ↗ |
| K033061 | CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE | Diamond Diagnostics, Inc. | 2003-11-07 | Traditional | PDF ↗ |
| K032287 | MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 | Beckman Coulter, Inc. | 2003-08-18 | Special | PDF ↗ |
| K031608 | RANDOX LIQUID PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2003-08-08 | Traditional | PDF ↗ |
| K031683 | TOX AMMONIA CALIBRATOR | Bayer Healthcare, LLC | 2003-08-06 | Abbreviated | PDF ↗ |
| K031880 | AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL | Roche Diagnostics Corp. | 2003-07-16 | Special | PDF ↗ |
| K031682 | LIPOPROTEIN CALIBRATOR | Bayer Healthcare, LLC | 2003-06-25 | Abbreviated | PDF ↗ |
| K030804 | BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR | Bayer Healthcare, LLC | 2003-04-10 | Abbreviated | PDF ↗ |
| K030621 | ATAC CALIBRATOR | Elan Diagnostics | 2003-03-19 | Traditional | PDF ↗ |
| K024305 | WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 | Wiener Laboratories Saic | 2003-03-18 | Traditional | PDF ↗ |
| K023792 | CALIBRATION PACK, MODELS A9100-101S AND A9100-103S | Thermo Orion | 2003-01-31 | Traditional | PDF ↗ |
| K030169 | SETPOINT CHEMISTRY CALIBRATOR | Bayer Healthcare, LLC | 2003-01-31 | Abbreviated | PDF ↗ |
| K030074 | LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS | Cliniqa Corporation | 2003-01-21 | Traditional | PDF ↗ |
| K023876 | VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | 2002-12-10 | Special | PDF ↗ |
| K023268 | PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS | Phoenix Diagnostics, Inc. | 2002-11-15 | Traditional | PDF ↗ |
| K023158 | RANDOX APOLIPOPROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2002-10-24 | Traditional | PDF ↗ |
| K022767 | RAICHEM LIPID CALIBRATOR | Hemagen Diagnostics, Inc. | 2002-09-03 | Special | PDF ↗ |
| K022108 | THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 | Thermo Dma, Inc. | 2002-07-25 | Traditional | PDF ↗ |
| K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION | Fisher Diagnostics | 2002-02-15 | Traditional | PDF ↗ |
| K020129 | PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE | Phoenix Diagnostics, Inc. | 2002-02-01 | Traditional | PDF ↗ |
| K013178 | DC-UIBC-CO2-CAL, MODEL SE-153 | Diagnostic Chemicals , Ltd. | 2001-12-18 | Traditional | PDF ↗ |
| K012987 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER | Phoenix Diagnostics, Inc. | 2001-11-07 | Traditional | PDF ↗ |
| K012509 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM | Phoenix Diagnostics, Inc. | 2001-10-09 | Traditional | PDF ↗ |
| K012470 | MODIFICATION TO N PROTEIN STANDARD SL | Dade Behring, Inc. | 2001-09-28 | Traditional | PDF ↗ |
| K012250 | RAICHEM MULTI-ANALYTE CALIBRATOR | Hemagen Diagnostics, Inc. | 2001-09-24 | Abbreviated | PDF ↗ |
| K011658 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS | Rochdiag | 2001-07-31 | Abbreviated | PDF ↗ |
| K011226 | CALIBRATOR FOR AUTOMATED SYSTEMS | Roche Diagnostics Corp. | 2001-06-25 | Abbreviated | PDF ↗ |
Product code JIX · Class II · Clinical Chemistry. Data: openFDA.