Single (Specified) Analyte Controls (Assayed And Unassayed)

JJX 2009-02-12

ELECSYS TOXO IGG CALCHECK

Applicant Roche Diagnostics

K number K083655

JJX 2008-12-22

ABT GLUCOSE CONTROL SOLUTION

Applicant American Biological Technologies, Inc.

K number K083549

JJX 2008-10-06

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS

Applicant Bionostics, Inc.

K number K081478

JJX 2008-09-18

GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002

Applicant Bionostics, Inc.

K number K082395

JJX 2008-08-22

ELECSYS ANTI-TSHR CALCHECK

Applicant Roche Diagnostics

K number K080643

JJX 2008-08-08

FDTX GLUCOSE CONTROL SOLUTION

Applicant Fujirebio Diagnostics Texas, Inc.

K number K081915

JJX 2008-08-08

AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION

Applicant Fujirebio Diagnostics Texas, Inc.

K number K080273

JJX 2008-07-25

GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK

Applicant Bionostics, Inc.

K number K081403

JJX 2008-02-27

ELECSYS PROBNP II CALCHECK

Applicant Roche Diagnostics Corp.

K number K080147

JJX 2007-08-22

EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS

Applicant Canterbury Scientific , Ltd.

K number K071648

JJX 2007-07-30

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY

Applicant Inverness Medical Innovations, Inc.

K number K071587

JJX 2007-04-18

SMS MULTI GLUCOSE CONTROL, MODEL 2120049

Applicant Medical Specialties Supply Co., Inc.

K number K070506

JJX 2007-04-12

SMS GLUCOSE CONTROL, MODEL 2120061

Applicant Spectrum Medical Supply, Inc.

K number K070649

JJX 2007-04-02

FASTPACK TOTAL PSA METHOD VERIFICATION KIT

Applicant Qualigen, Inc.

K number K062957

JJX 2007-02-01

LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047

K number K063855

JJX 2006-10-13

PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS

Applicant Roche Diagnostics Corp.

K number K062972

JJX 2006-09-29

VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901

Applicant Maine Standards Co.

K number K062501

JJX 2006-06-19

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT

Applicant Drew Scientific , Ltd.

K number K060510

JJX 2006-04-28

LIBERTY NORMAL GLUCOSE CONTROL SOLUTION

K number K060706

JJX 2006-04-13

HEMOGLOBIN ALC CONTROL

Applicant Compass Bioscience

K number K060570

JJX 2006-03-24

ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002

Applicant Eurotrol B.V.

K number K060215

JJX 2006-03-09

LIBERTY GLUCOSE CONTROL SOLUTION

K number K060481

JJX 2006-03-09

LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041

K number K060426

JJX 2006-02-16

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

Applicant Inverness Medical Innovations, Inc.

K number K060133

JJX 2006-01-26

ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

Applicant Biokit, S.A.

K number K060027

JJX 2006-01-26

OXICOM CONTROL

Applicant Bionostics, Inc.

K number K053327

JJX 2005-11-30

LIBERTY GLUCOSE CONTROL, MODEL 2120031

K number K052980

JJX 2005-11-28

ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK

Applicant Roche Diagnostics

K number K053059

JJX 2005-11-18

CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E

Applicant Cliniqa Corporation

K number K052679

JJX 2005-10-04

HBA1C LINEARITY SET

Applicant Cone Bioproducts

K number K052010

JJX 2005-05-16

IRMA TRUPOINT CREATININE CONTROL KIT

Applicant International Technidyne Corporation

K number K050983

JJX 2005-05-13

RNA1C CONTROL FOR NYCOCARD HBA1C

Applicant Bionostics, Inc.

K number K050961

JJX 2005-03-29

PREGNANCY-SKREEN

Applicant Biochemical Diagnostic, Inc.

K number K050328

JJX 2005-02-25

RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER

Applicant Bionostics, Inc.

K number K050100

JJX 2005-02-08

LIQUICHEK BNP CONTROL

Applicant Bio-Rad Laboratories, Inc.

K number K043584

JJX 2004-12-17

MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II

Applicant Roche Diagnostics Corp.

K number K043320

JJX 2004-12-09

LIQUID STABLE HBA1C CONTROL

Applicant Canterbury Scientific , Ltd.

K number K043070

JJX 2004-11-05

MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL

K number K042717

JJX 2004-11-02

LIQUICHEK ELEVATED CRP CONTROL

Applicant Bio-Rad

K number K042837

JJX 2004-10-29

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

Applicant General Atomics

K number K042448

JJX 2004-09-27

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

K number K042303

JJX 2004-08-19

TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM

Applicant Home Diagnostics, Inc.

K number K042080

JJX 2004-08-18

ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR

Applicant Abbott Laboratories

K number K041687

JJX 2004-08-16

CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM

Applicant Cliniqa Corporation

K number K041898

JJX 2004-08-16

INTERLAB MICROCAL SERUM CONTROLS

Applicant Trouble Shooter Consuling, Inc.

K number K041871

JJX 2004-08-16

ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H

K number K041194

JJX 2004-05-17

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS

Applicant Cliniqa Corporation

K number K040927

JJX 2004-05-17

WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2

Applicant Wako Chemicals USA, Inc.

K number K040918

JJX 2004-05-07

NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS

Applicant Nova Biomedical Corp.

K number K041016

JJX 2004-03-12

RANDOX LIQUID CRP CONTROLS

Applicant Randox Laboratories, Ltd.

K number K040351

JJX 2004-03-10

R&D GLU-LINE HEMATOLOGY CONTROL

Applicant R&D Systems, Inc.

K number K034048

JJX 2004-03-05

LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS

Applicant Cliniqa Corporation

K number K040455

JJX 2004-03-02

A1C-CELLULAR

Applicant Streck Laboratories, Inc.

K number K040025

JJX 2004-02-25

ELECSYS C-PEPTIDE CALCHECK

Applicant Roche Diagnostics Corp.

K number K040157

JJX 2004-02-02

AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1

Applicant N-Dia, Inc.

K number K030849

JJX 2004-01-02

NOVA GLUCOSE CONTROL SOLUTIONS

Applicant Nova Biomedical Corp.

K number K033433

JJX 2003-10-31

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS

K number K033127

JJX 2003-10-31

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K032993

JJX 2003-10-20

GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM

Applicant Bionostics, Inc.

K number K032819

JJX 2003-10-07

I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET

Applicant I-Stat Corporation

K number K031873

JJX 2003-08-20

ELECSYS PRECICONTROL TROPONIN T

Applicant Roche Diagnostics Corp.

K number K031990

JJX 2003-08-20

ELECYS SHBG CALCHECK

Applicant Roche Diagnostics Corp.

K number K031698

JJX 2003-07-16

MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

K number K031890

JJX 2003-03-17

SAS RSV CONTROL KIT

Applicant Sa Scientific, Inc.

K number K030628

JJX 2003-02-11

WAKO NEFA LINEARITY SET

Applicant Wako Chemicals USA, Inc.

K number K030065

JJX 2002-11-29

ELECSYS PROBNP CALCHECK

Applicant Roche Diagnostics Corp.

K number K020883

JJX 2002-11-13

LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION

Applicant Bionostics, Inc.

K number K022769

JJX 2002-10-31

MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL

K number K023307

JJX 2002-09-23

CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013

Applicant Good Biotech Corp.

K number K022725

JJX 2002-09-17

LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER

Applicant Cliniqa Corporation

K number K022758

JJX 2002-08-27

LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS

Applicant Cliniqa Corporation

K number K022491

JJX 2002-08-01

CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3

Applicant Cliniqa Corporation

K number K022232

JJX 2002-07-12

GLUCOSE CONTROL SOLUTION FOR BD LATITUDE

Applicant Bionostics, Inc.

K number K021697

JJX 2002-07-12

RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4

Applicant Bionostics, Inc.

K number K021624

JJX 2002-03-15

ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY

Applicant Bayer Diagnostics Corp.

K number K020217

JJX 2002-03-06

ELECSYS ANTI-TG CALCHECK

Applicant Roche Diagnostics Corp.

K number K020369

JJX 2001-12-21

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS

K number K013900

JJX 2001-11-16

VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006

Applicant Maine Standards Co.

K number K013119

JJX 2001-10-24

GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE

Applicant Bionostics, Inc.

K number K013147

JJX 2001-10-18

N LP(A) CONTROL SY

Applicant Dade Behring, Inc.

K number K013130

JJX 2001-08-29

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS

K number K012561

JJX 2001-08-27

MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3

Applicant Bionostics, Inc.

K number K012430

JJX 2001-08-20

VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005

Applicant Maine Standards Co.

K number K012122

JJX 2001-06-13

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS

K number K011463

JJX 2001-06-13

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K011250

JJX 2001-04-11

VIGIL DNASE B CONTROL

Applicant Beckman Coulter, Inc.

K number K010693

JJX 2001-03-13

ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349

Applicant Beckman Coulter, Inc.

K number K010428

JJX 2001-02-14

ELECSYS HCG+B CALCHECK

Applicant Roche Diagnostics Corp.

K number K010237

JJX 2001-01-12

CA 125 II CALCHECK

Applicant Roche Diagnostics Corp.

K number K003967

JJX 2000-12-20

ELECSYS DHEA-S CALCHECK

Applicant Roche Diagnostics Corp.

K number K003772

JJX 2000-11-29

FASTPACK CONTROL

Applicant Qualigen, Inc.

K number K003095

JJX 2000-11-22

BIO-RAD %CDT TIA

Applicant Axis-Shield Biochemicals, Asa

K number K001651

JJX 2000-11-02

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K003112

JJX 2000-09-18

BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS

Applicant Bionostics, Inc.

K number K002540

JJX 2000-06-29

SUGAR CHEX ONE

Applicant Streck Laboratories, Inc.

K number K001443

JJX 2000-06-28

ELECSYS INSULIN CALCHECK

Applicant Roche Diagnostics Corp.

K number K001846

JJX 2000-06-02

SYNCHRON CONTROL

Applicant Beckman Coulter, Inc.

K number K001458

JJX 2000-06-01

ELECSYS ANTI-TPO CALCHECK

Applicant Roche Diagnostics Corp.

K number K001014

JJX 2000-04-27

ELECSYS THYROGLOBULIN CALCHECK

Applicant Roche Diagnostics Corp.

K number K001015