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

510(k), Device, Applicant table
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

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
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
10673486013962	Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TECO DIAGNOSTICS	2025-05-28
08430793040570	Aptiva® Celiac Disease IgA Calibrators	INOVA DIAGNOSTICS, INC.	2022-05-27
08430793040518	Aptiva® Celiac Disease IgG Calibrators	INOVA DIAGNOSTICS, INC.	2022-05-27
14987481102924	Multi Calibrator Lipids	FUJIFILM WAKO PURE CHEMICAL CORPORATION	2020-10-23
00380740161378	ARCHITECT	Abbott GmbH	2020-09-18
08058056680532	Plasmaproteins Cal 3x	SENTINEL CH. SPA	2018-11-15
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
00385480141826	NOVA	NOVA BIOMEDICAL CORPORATION	2016-09-20
00385480095839	NOVA	NOVA BIOMEDICAL CORPORATION	2016-09-16
00385480142533	NOVA	NOVA BIOMEDICAL CORPORATION	2016-09-16
00385480112727	NOVA	NOVA BIOMEDICAL CORPORATION	2016-09-16
00385480115339	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	2016-09-16
00385480127042	NOVA/STAT PROFILE	NOVA BIOMEDICAL CORPORATION	2016-09-16
08426950595830	QUANTA Flash® DGP Screen Calibrators	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950595120	QUANTA Flash® GBM Calibrators	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950595083	QUANTA Flash® DGP IgA Calibrators	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950595021	QUANTA Flash® h-tTG IgG Calibrators	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950594758	QUANTA Flash® DGP IgG Calibrators	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950554547	QUANTA Flash® MPO Calibrators	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950554509	QUANTA Flash® h-tTG IgA 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
00380740002022	ARCHITECT	Abbott GmbH	2016-06-06
00380740002046	ARCHITECT	Abbott GmbH	2016-06-06

Product code JIX

Related 510(k) Records#

Related GUDID Devices#