Product code JIX
- Device name
- Calibrator, Multi-Analyte Mixture
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1150
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | 2016-05-20 |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | 2015-12-18 |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | Elitechgroup | 2015-07-08 |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | Siemens Healthcare Diagnostics | 2015-06-15 |
| K141388 | SYSTEM CALIBRATER | Beckman Coulter Ireland, Inc. | 2014-07-11 |
| 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 |
| K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | Elitechgroup | 2013-04-04 |
| K123321 | DIMENSION CHEMISTRY III CALIBRATORY | Siemens Healthcare Diagnostics | 2013-02-15 |
| K123372 | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR | Abbott Laboratories | 2013-01-14 |
| K122398 | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2012-10-12 |
| 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 |
| K112029 | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 | Elitechgroup | 2011-08-30 |
| K110394 | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-09 |
| K110251 | SYNCHRON MULTI CALIBRATOR | Beckman Coulter, Inc. | 2011-05-25 |
| K103701 | ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2011-02-18 |
| K103171 | ELECSYS ANTI-TPO CALSET | Roche Diagnostics | 2011-02-11 |
| K103403 | MULTICONSTITUENT CALIBRATOR | Abbott Laboratories | 2011-02-04 |
| K103612 | DIMENSION VISA ENZ 2 CAL | Siemens Healthcare Diagnostics, Inc. | 2011-01-25 |
| K101456 | ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM | Roche Diagnostics | 2010-09-08 |
| K101460 | LOCI 8 CALIBRATOR, MODEL KC 646 | Siemens Healthcare Diagnostics | 2010-07-09 |
| K100778 | DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A | Siemens Healthcare Diagnostics | 2010-05-05 |
| K093732 | ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 | Siemens Healthcare Diagnostics | 2010-03-22 |
| K093645 | EXL ANEM CAL, MODEL RC640 | Siemens Healthcare Diagnostics | 2010-03-05 |
| K092113 | STA - FREE PS CALIBRATOR | Diagnostica Stago, Inc. | 2009-11-13 |
| K090283 | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 | Genchem, Inc. | 2009-06-05 |
| K080404 | EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR | Medica Corp. | 2009-03-13 |
| K083579 | DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 | Siemens Healthcare Diagnostics | 2009-02-20 |
| K081533 | SENTINEL PLASMAPROTEINS CAL 3X | SENTINEL CH. SpA | 2008-06-25 |
| K073612 | URIC ACID (AOX), SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-05-23 |
| K081103 | LOCI THYROID CALIBRATOR WITH MODEL RC610 | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10673486014136 | Teco Diagnostics TC Chemistry Calibrator I | TECO DIAGNOSTICS | 2026-08-25 |
| 08430793040839 | Aptiva® APS IgA Calibrators | INOVA DIAGNOSTICS, INC. | 2026-06-10 |
| 10673486013962 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013894 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013726 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013580 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 08430793040907 | Aptiva® APS IgM Calibrators | INOVA DIAGNOSTICS, INC. | 2024-03-11 |
| 08430793040761 | Aptiva® APS IgG Calibrators | INOVA DIAGNOSTICS, INC. | 2024-03-11 |
| 08430793040181 | Aptiva® CTD Essential Calibrators | INOVA DIAGNOSTICS, INC. | 2023-12-14 |
| 08430793040518 | Aptiva® Celiac Disease IgG Calibrators | INOVA DIAGNOSTICS, INC. | 2022-05-27 |
| 08430793040570 | Aptiva® Celiac Disease IgA Calibrators | INOVA DIAGNOSTICS, INC. | 2022-05-27 |
| 14987481102924 | Multi Calibrator Lipids | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2020-10-23 |
| 08058056680532 | Plasmaproteins Cal 3x | SENTINEL CH. SPA | 2018-11-15 |
| 00630414597515 | Atellica CH CRP_2 Calibrator | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 00630414597508 | Atellica CH hsCRP Calibrator | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 08426950554578 | QUANTA Flash® PR3 Calibrators | INOVA DIAGNOSTICS, INC. | 2017-08-28 |
| 10629009041059 | Visu-Cal F Frozen Calibrator Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 10629009041257 | VisuCal-F Frozen Calibrator Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 08426950596080 | QUANTA Flash® Centromere Calibrators | INOVA DIAGNOSTICS, INC. | 2016-09-30 |
| 00628063400836 | MICROALBUMIN Calibrators | Sekisui Diagnostics, LLC | 2016-09-20 |
| 00628063400447 | DC-CAL Calibrator | Sekisui Diagnostics, LLC | 2016-09-20 |
| 08426950554509 | QUANTA Flash® h-tTG IgA Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950554547 | QUANTA Flash® MPO Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594758 | QUANTA Flash® DGP IgG Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595021 | QUANTA Flash® h-tTG IgG Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595083 | QUANTA Flash® DGP IgA Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595120 | QUANTA Flash® GBM Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595830 | QUANTA Flash® DGP Screen Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08058056681799 | Lipase NG Cal | SENTINEL CH. SPA | 2016-08-07 |
| 08058056681300 | Plasmaproteins Cal 3x | SENTINEL CH. SPA | 2016-06-29 |