Multi-Analyte Controls, All Kinds (Assayed)

JJY 2017-03-10

Audit MicroControls Linearity FD Tumor Markers II

Applicant Aalto Scientific, Ltd.

K number K163629

JJY 2017-01-10

Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

Applicant Bio-Rad Laboratories

K number K163015

JJY 2016-01-28

VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

Applicant Radiometer America, Inc.

K number K153712

JJY 2013-10-25

LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY

Applicant Bio-Rad Laboratories

K number K132227

JJY 2013-10-23

RANDOX CSF CONTROLS LEVELS 2 AND 3

K number K132156

JJY 2013-10-22

MULTICHEM S PLUS / S PLUS (ASSAYED)

K number K132751

JJY 2013-10-15

MULTICHEM U

K number K131993

JJY 2013-10-07

V8 SP NORMAL CONTROL, ABNORMAL CONTROL

Applicant Helena Laboratories

K number K131479

JJY 2013-09-25

MULTICHEM P

K number K131992

JJY 2013-09-20

MULTICHEM IA AND IA PLUS

K number K132091

JJY 2013-07-26

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM

Applicant Eurotrol B.V.

K number K131595

JJY 2013-06-19

RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3

Applicant Randox Laboratories Limited

K number K130337

JJY 2013-05-06

LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK

Applicant Bio-Rad Laboratories, Inc.

K number K130963

JJY 2013-04-29

AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K130762

JJY 2013-04-17

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C

K number K124009

JJY 2013-04-12

LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK

Applicant Bio-Rad Laboratories

K number K130761

JJY 2013-03-08

FASTPACK CONTROL KIT

Applicant Qualigen, Inc.

K number K123725

JJY 2013-03-01

LIQUID ASSAYED MULTIQUAL PREMIUM

Applicant Bio-Rad Laboratories

K number K130162

JJY 2013-01-31

LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK

Applicant Bio-Rad Laboratories

K number K123775

JJY 2012-12-27

LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

Applicant Bio-Rad Laboratories

K number K123663

JJY 2012-11-20

LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA

Applicant Bio-Rad Laboratories

K number K123198

JJY 2012-11-20

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3

K number K121603

JJY 2012-10-17

LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK

Applicant Bio-Rad Laboratories

K number K122838

JJY 2012-09-20

RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3

K number K113720

JJY 2012-08-31

THERMO SCIENTIFIC MAS OMNI-CARDIO

Applicant Microgenics Corporation

K number K122291

JJY 2012-07-24

CONE-TROL LIQUID CHEMISTRY CONTROLS

Applicant Cone Bioproducts

K number K121759

JJY 2012-07-11

LIQUICHEK URINE CHEMISTRY CONTROL

Applicant Bio-Rad, Diagnostics Grp.

K number K121794

JJY 2012-06-22

EUROTROL GAS-ISE METABOLITES

Applicant Eurotrol B.V.

K number K121468

JJY 2012-06-15

AUDIT MICROLQ SPINAL FLUID CONTROL

Applicant Aalto Scientific, Ltd.

K number K112742

JJY 2012-03-02

AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

Applicant Aalto Scientific, Ltd.

K number K111964

JJY 2012-01-24

AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL

Applicant Aalto Scientific, Ltd.

K number K112705

JJY 2012-01-23

RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

Applicant Randox Laboratories Limited

K number K110534

JJY 2011-12-01

RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL

K number K112337

JJY 2011-11-07

IT/IF CONTROL

Applicant Sebia

K number K101863

JJY 2011-11-03

THERMO SCIENTIFIC MAS OMNI-CORE

Applicant Microgenics Corporation

K number K110738

JJY 2011-09-30

RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3

K number K110904

JJY 2011-09-14

ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2

Applicant Elitechgroup

K number K111996

JJY 2011-07-08

ELECSYS PRECICONTROL VARIA 3

Applicant Roche Diagnostics

K number K111506

JJY 2011-07-05

VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT

Applicant Maine Standards Company, LLC

K number K110880

JJY 2011-06-29

THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO

Applicant Microgenics Corp.

K number K110616

JJY 2011-06-28

VITAL SERUM CONTROLS

Applicant Vital Diagnostics (Manufacturing) Ptyltd

K number K111063

JJY 2011-06-10

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K103601

JJY 2011-05-06

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL

K number K103364

JJY 2011-01-25

MSC LIPID CONTROL

Applicant Maine Standards Co.

K number K103271

JJY 2011-01-14

AUDIT MICROCV PROTEIN LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K101216

JJY 2011-01-10

AUDIT MICROCV CARDIAC MARKERS LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K102617

JJY 2010-12-21

LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS

Applicant Alere, San Diego, Dba Biosite INcorporated, Dba IN

K number K102700

JJY 2010-10-05

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

Applicant Fujirebio Diagnostics,Inc.

K number K101809

JJY 2010-09-14

LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK

Applicant Bio-Rad, Diagnostics Grp.

K number K100727

JJY 2010-09-03

AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5

Applicant Aalto Scientific, Ltd.

K number K100718

JJY 2010-09-01

PRECICONTROL CLINCHEM MULTI 1 AND 2

Applicant Roche Diagnostics

K number K102016

JJY 2010-08-31

AUDIT MICROCV RF/CRP LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K101226

JJY 2010-08-27

ELECSYS PRECICONTROL MULTIMARKER

Applicant Roche Diagnostics

K number K102157

JJY 2010-08-27

NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH

Applicant Nova Biomedical Corp.

K number K101633

JJY 2010-03-19

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR

K number K093492

JJY 2010-03-10

MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)

K number K093384

JJY 2009-11-13

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET

Applicant Biosite Incorporated

K number K093032

JJY 2009-11-03

ELECSYS PRECICONTROL THYROAB

Applicant Roche Diagnostics

K number K092320

JJY 2009-09-21

THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158

Applicant Microgenics Corp.

K number K092051

JJY 2009-07-02

ELECSYS PRECICONTROL UNIVERSAL

Applicant Roche Diagnostics

K number K090541

JJY 2009-06-25

VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET

Applicant Maine Standards Co.

K number K091225

JJY 2009-04-21

CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3

Applicant Cliniqa Corporation

K number K083554

JJY 2009-04-16

VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402

Applicant Maine Standards Co.

K number K090475

JJY 2009-03-23

VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901

Applicant Maine Standards Co.

K number K083891

JJY 2008-11-19

AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5

Applicant Aalto Scientific, Ltd.

K number K082714

JJY 2008-10-30

AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5

Applicant Aalto Scientific, Ltd.

K number K082717

JJY 2008-09-17

CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2

Applicant Cliniqa Corporation

K number K082107

JJY 2008-09-08

LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK

Applicant Bio-Rad Laboratories

K number K082036

JJY 2008-08-22

MSC LIPID CONTROL

Applicant Maine Standards Co.

K number K082067

JJY 2008-06-02

CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC

Applicant Cliniqa Corporation

K number K080973

JJY 2008-01-24

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

Applicant Bio-Rad Laboratories

K number K073080

JJY 2007-12-11

LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK

Applicant Bio-Rad, Diagnostics Grp.

K number K072835

JJY 2007-12-07

TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5

Applicant Biosite Incorporated

K number K072892

JJY 2007-09-14

VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601

Applicant Maine Standards Co.

K number K072246

JJY 2007-09-11

DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H

Applicant Dade Behring, Inc.

K number K071980

JJY 2007-07-03

LIQUICHEK TUMOR MARKER CONTROL

Applicant Bio-Rad Laboratories

K number K071675

JJY 2007-06-28

SMS GLUCOSE CONTROL, MODEL 2120059

Applicant Specialty Medical Supplies

K number K071433

JJY 2007-05-04

CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3

Applicant Cliniqa Corporation

K number K070741

JJY 2007-04-11

AMMONIA/ALCOHOL CONTROL SET

Applicant Pointe Scientific, Inc.,

K number K070504

JJY 2007-03-19

TDM CONTROL SET, MODEL CAT# 04521536

Applicant Roche Diagnostics Corp.

K number K070200

JJY 2007-03-13

AUDIT MICROCV LIPIDS LINEARITY SET (LOW)

Applicant Aalto Scientific, Ltd.

K number K070223

JJY 2007-01-31

COBAS INTEGRA CERULOPLASMIN

Applicant Roche Diagnostics Corp.

K number K062379

JJY 2006-12-01

MISSION TRINITY B

K number K062674

JJY 2006-11-22

CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET

Applicant Compass Bioscience

K number K062593

JJY 2006-10-23

CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3

Applicant Cliniqa Corporation

K number K062916

JJY 2006-10-16

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K062668

JJY 2006-07-06

ADVIA IMS CPSA CONTROL

Applicant Bayer Healthcare, LLC

K number K061137

JJY 2006-05-30

CARDIOIMMUNE XL CARDIAC MARKER CONTROL

Applicant Microgenics Corp.

K number K061196

JJY 2006-05-30

NOD CHEMISTRY CONTROL

Applicant Bioresource Technology, Inc.

K number K060850

JJY 2006-05-25

CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB

Applicant Cliniqa Corporation

K number K061182

JJY 2006-03-21

MISSION COMPLETE

K number K060206

JJY 2006-03-15

TDM CONTROL SET

Applicant Roche Diagnostics Corp.

K number K060429

JJY 2006-01-13

VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET

Applicant Maine Standards Co.

K number K053247

JJY 2005-10-17

ELECSYS PRECICONTROL BONE

Applicant Roche Diagnostics Corp.

K number K051543

JJY 2005-10-12

AUTOCHECK6+

Applicant Radiometer Medical Aps

K number K051928

JJY 2005-09-23

DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM

Applicant Thermo-Electron Corp.

K number K052056

JJY 2005-07-25

ELECSYS PRECICONTROL UNIVERSAL

Applicant Roche Diagnostics Corp.

K number K051687

JJY 2005-07-06

ELECSYS CA 19-9 CALCHECK

Applicant Roche Diagnostics Corp.

K number K051185

JJY 2005-07-05

ELECSYS PRECICONTROL ANEMIA

Applicant Roche Diagnostics Corp.

K number K051517