Calibrator, Multi-Analyte Mixture

K number K161140

JIX 2013-11-26

C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN

Applicant Roche Diagnostics

K number K133330

JIX 2013-04-04

ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II

Applicant Elitechgroup

K number K130765

JIX 2013-02-15

DIMENSION CHEMISTRY III CALIBRATORY

K number K123321

JIX 2013-01-14

ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR

Applicant Abbott Laboratories

K number K123372

JIX 2012-10-12

RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS

K number K122398

JIX 2012-03-28

MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES

Applicant Verichem Laboratories, Inc.

K number K112834

JIX 2011-08-30

ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05

Applicant Elitechgroup

K number K112029

JIX 2011-06-09

ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

Applicant Vital Diagnostics (Manufacturing) Ptyltd

K number K110394

JIX 2011-05-25

SYNCHRON MULTI CALIBRATOR

Applicant Beckman Coulter, Inc.

K number K110251

JIX 2011-02-18

ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS

K number K103701

JIX 2011-02-11

ELECSYS ANTI-TPO CALSET

Applicant Roche Diagnostics

K number K103171

JIX 2011-02-04

MULTICONSTITUENT CALIBRATOR

Applicant Abbott Laboratories

K number K103403

JIX 2011-01-25

DIMENSION VISA ENZ 2 CAL

K number K103612

JIX 2010-09-08

ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM

Applicant Roche Diagnostics

K number K101456

JIX 2010-07-09

LOCI 8 CALIBRATOR, MODEL KC 646

K number K101460

JIX 2010-05-05

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

K number K100778

JIX 2010-03-22

ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770

K number K093732

JIX 2010-03-05

EXL ANEM CAL, MODEL RC640

K number K093645

JIX 2009-11-13

STA - FREE PS CALIBRATOR

Applicant Diagnostica Stago, Inc.

K number K092113

JIX 2009-06-05

CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3

Applicant Genchem, Inc.

K number K090283

JIX 2009-03-13

EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR

Applicant Medica Corp.

K number K080404

JIX 2009-02-20

DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

K number K083579

JIX 2008-06-25

SENTINEL PLASMAPROTEINS CAL 3X

Applicant SENTINEL CH. SpA

K number K081533

JIX 2008-05-23

LOCI THYROID CALIBRATOR WITH MODEL RC610

K number K081103

JIX 2008-05-23

URIC ACID (AOX), SCAL, NORTROL, ABTROL

Applicant Thermofisher Scientific OY

K number K073612

JIX 2008-05-12

CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160

Applicant Roche Diagnostics Corp.

K number K080607

JIX 2008-03-05

ABX PENTRA URINE CAL

Applicant Horiba Abx

K number K071779

JIX 2007-10-17

DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H

Applicant Dade Behring, Inc.

K number K072435

JIX 2007-10-05

ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS

Applicant Siemens Medical Solutions Diagnostics

K number K072204

JIX 2007-07-20

VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659

K number K071801

JIX 2007-05-23

MODIFICATION TO SENTINEL CLIN CHEM CAL

Applicant Sentinel Ch. Srl

K number K070971

JIX 2007-04-13

MULTI-ANALYTE CHEMISTRY CALIBRATOR

Applicant Pointe Scientific, Inc.,

K number K070207

JIX 2007-01-23

DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN

Applicant Dade Behring, Inc.

K number K063508

JIX 2006-10-04

DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL

Applicant Dade Behring, Inc.

K number K062035

JIX 2006-09-22

DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130

Applicant Dade Behring, Inc.

K number K062334

JIX 2006-09-13

CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360

Applicant Roche Diagnostics Corp.

K number K062319

JIX 2006-09-06

DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)

Applicant Dade Behring, Inc.

K number K062034

JIX 2006-08-25

DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)

Applicant Dade Behring, Inc.

K number K062122

JIX 2006-08-25

DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)

Applicant Dade Behring, Inc.

K number K061923

JIX 2006-08-21

DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110

Applicant Dade Behring, Inc.

K number K061838

JIX 2006-08-11

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220

Applicant Dade Behring, Inc.

K number K061750

JIX 2006-08-07

DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH

Applicant Dade Behring, Inc.

K number K062055

JIX 2006-08-02

DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)

Applicant Dade Behring, Inc.

K number K061703

JIX 2006-07-20

RANDOX LIQUID PROTEIN CALIBRATOR

K number K061056

JIX 2006-07-05

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

Applicant Dade Behring, Inc.

K number K061390

JIX 2006-06-30

DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140

Applicant Dade Behring, Inc.

K number K061218

JIX 2006-04-24

VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III

K number K060940

JIX 2006-01-13

RANDOX CALIBRATION SERUM

K number K053153

JIX 2005-10-25

SENTINEL CLIN CHEM CAL

Applicant Sentinel Ch. Srl

K number K051452

JIX 2005-08-01

LIPOPROTEIN FOR MULTIPLE ANALYTES

Applicant Bayer Healthcare, LLC

K number K051619

JIX 2005-07-25

SENTINEL PLASMAPROTEINS CAL 3X

Applicant Sentinel Ch. Srl

K number K051457

JIX 2005-01-31

PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC

Applicant Roche Diagnostics

K number K050026

JIX 2005-01-31

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071

Applicant Olympus America, Inc.

K number K043460

JIX 2004-11-23

HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278

Applicant Diagnostic Chemicals , Ltd.

K number K041926

JIX 2004-11-16

MULTI-CHEM CALIBRATOR A

Applicant Wako Chemicals USA, Inc.

K number K042551

JIX 2004-11-08

MULTI-LIPID CALIBRATOR

Applicant Wako Chemicals USA, Inc.

K number K042550

JIX 2004-11-08

MULTI CHEM CAL B

Applicant Wako Chemicals USA, Inc.

K number K042549

JIX 2004-10-04

MICROALBUMIN MULTI-CALIBRATOR SET

Applicant Diagnostic Chemicals , Ltd.

K number K042243

JIX 2004-09-28

HEMOSIL CALIBRATION PLASMA

Applicant Instrumentation Laboratory CO

K number K041905

JIX 2004-07-27

N APOLIPOPROTEIN STANDARD SERUM

Applicant Dade Behring, Inc.

K number K041870

JIX 2004-04-02

CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF

Applicant Roche Diagnostics Corp.

K number K040264

JIX 2004-03-24

CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)

Applicant Roche Diagnostics Corp.

K number K040245

JIX 2004-03-12

DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR

Applicant Stanbio Laboratory

K number K032936

JIX 2004-02-13

ELECSYS C-PEPTIDE CALSET

Applicant Roche Diagnostics Corp.

K number K033873

JIX 2004-02-13

BAYER SPECIFIC PROTEIN REFERENCE SERUM

Applicant Bayer Healthcare, LLC

K number K033791

JIX 2004-01-30

OLYMPUS URINE CALIBRATOR

Applicant Cliniqa Corporation

K number K033910

JIX 2003-12-16

BAYER SPECIAL CHEMISTRY CALIBRATORS

Applicant Bayer Diagnostics Corp.

K number K033380

JIX 2003-11-21

OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071

Applicant Olympus America, Inc.

K number K032665

JIX 2003-11-20

MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)

Applicant Roche Diagnostics Corp.

K number K033501

JIX 2003-11-07

CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE

Applicant Diamond Diagnostics, Inc.

K number K033061

JIX 2003-08-18

MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

Applicant Beckman Coulter, Inc.

K number K032287

JIX 2003-08-08

RANDOX LIQUID PROTEIN CALIBRATOR

K number K031608

JIX 2003-08-06

TOX AMMONIA CALIBRATOR

Applicant Bayer Healthcare, LLC

K number K031683

JIX 2003-07-16

AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL

Applicant Roche Diagnostics Corp.

K number K031880

JIX 2003-06-25

LIPOPROTEIN CALIBRATOR

Applicant Bayer Healthcare, LLC

K number K031682

JIX 2003-04-10

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

Applicant Bayer Healthcare, LLC

K number K030804

JIX 2003-03-19

ATAC CALIBRATOR

Applicant Elan Diagnostics

K number K030621

JIX 2003-03-18

WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006

Applicant Wiener Laboratories Saic

K number K024305

JIX 2003-01-31

SETPOINT CHEMISTRY CALIBRATOR

Applicant Bayer Healthcare, LLC

K number K030169

JIX 2003-01-31

CALIBRATION PACK, MODELS A9100-101S AND A9100-103S

Applicant Thermo Orion

K number K023792

JIX 2003-01-21

LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS

Applicant Cliniqa Corporation

K number K030074

JIX 2002-12-10

VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

K number K023876

JIX 2002-11-15

PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS

K number K023268

JIX 2002-10-24

RANDOX APOLIPOPROTEIN CALIBRATOR

K number K023158

JIX 2002-09-03

RAICHEM LIPID CALIBRATOR

Applicant Hemagen Diagnostics, Inc.

K number K022767

JIX 2002-07-25

THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050

Applicant Thermo Dma, Inc.

K number K022108

JIX 2002-02-15

PACIFIC HEMOSTASIS REFERENCE EMULSION

Applicant Fisher Diagnostics

K number K013397

JIX 2002-02-01

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

K number K020129

JIX 2001-12-18

DC-UIBC-CO2-CAL, MODEL SE-153

Applicant Diagnostic Chemicals , Ltd.

K number K013178

JIX 2001-11-07

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER

K number K012987

JIX 2001-10-09

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM

K number K012509

JIX 2001-09-28

MODIFICATION TO N PROTEIN STANDARD SL

Applicant Dade Behring, Inc.

K number K012470

JIX 2001-09-24

RAICHEM MULTI-ANALYTE CALIBRATOR

Applicant Hemagen Diagnostics, Inc.

K number K012250

JIX 2001-07-31

CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS

Applicant Rochdiag

K number K011658

JIX 2001-06-25

CALIBRATOR FOR AUTOMATED SYSTEMS

Applicant Roche Diagnostics Corp.

K number K011226

JIX 2001-06-14

DIMENSION DRUG CALIBRATOR, MODEL DC22B

Applicant Dade Behring, Inc.

K number K011035

JIX 2001-03-30

SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936

Applicant Sigma Diagnostics, Inc.

K number K010652

JIX 2001-02-14

LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR

Applicant Synergent Biochem Inc.-Clinical Controls Div.

K number K010030

JIX 2000-10-05

N PROTEIN STANDARD SL

Applicant Dade Behring, Inc.

K number K002804