Single (Specified) Analyte Controls (Assayed And Unassayed)

JJX 2017-01-12

Elecsys CYFRA 21-1 CalCheck 5

Applicant Roche Diagnostics

K number K162173

JJX 2016-10-26

Multichem A1c

Applicant Technopath Manufacturing

K number K162514

JJX 2016-08-10

Audit MicroControls Linearity DROP LQ Blood Glucose

Applicant Aalto Scientific, Ltd.

K number K161874

JJX 2016-06-30

LIAISON CMV IgM Serum Control Set

Applicant DiaSorin, Inc.

K number K161526

JJX 2016-06-30

LIAISON EBV IgM Serum Control Set

Applicant DiaSorin, Inc.

K number K161522

JJX 2016-05-17

IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers

K number K161082

JJX 2016-04-21

Dropper hsCRP High Sensitivity CRP Control

Applicant Quantimetrix Corporation

K number K152117

JJX 2013-11-22

ELECSYS CK-MB CALCHECK 5

Applicant Roche Diagnostics

K number K133284

JJX 2013-10-30

IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)

K number K133122

JJX 2013-10-25

IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA

K number K133124

JJX 2013-10-24

RIGHTEST CONTROL SOLUTION

Applicant Bionime Corporation

K number K133003

JJX 2013-10-22

IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION

K number K133128

JJX 2013-10-10

IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL

K number K131662

JJX 2013-09-20

IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL

Applicant Siemens Helathcare Diagnostics, Inc.

K number K132391

JJX 2013-08-12

IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL

K number K131536

JJX 2013-07-26

HBA1C CONTROL, LEVEL 1 AND LEVEL 2

K number K131999

JJX 2013-07-18

ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

K number K131776

JJX 2013-06-14

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

Applicant Maine Standards Co.

K number K123127

JJX 2013-05-31

GLUCOSE METER-CHECK SOLUTION FOR TAIDOC

Applicant Bionostics, Inc.

K number K131136

JJX 2013-04-26

AUDIT MICROCV VITAMIN D LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K130764

JJX 2013-03-19

AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K130157

JJX 2013-03-14

IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL

K number K122534

JJX 2013-02-14

GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK

Applicant Bionostics, Inc.

K number K123851

JJX 2013-01-25

GLUCOSE METER-CHECK SOLUTION FOR BAYER

Applicant Bionostics, Inc.

K number K123966

JJX 2013-01-17

FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

K number K123612

JJX 2013-01-09

LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

Applicant Bio-Rad Laboratories

K number K123798

JJX 2012-12-05

ELECSYS CA 15-3 II CALCHECK 5

Applicant Roche Diagnostics

K number K122242

JJX 2012-08-24

ELECSYS HSV-2 IGG IMMUNOASSAY

Applicant Roche Diagnostics

K number K121895

JJX 2012-08-07

IDS-ISYS IGF-I CALIBRATION VERIFIERS

K number K122141

JJX 2012-07-11

RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)

K number K121746

JJX 2012-06-20

RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3

K number K121588

JJX 2012-06-20

CONE-TROL HEMOGLOBIN A1C CONTROL SET

Applicant Cone Bioproducts

K number K121534

JJX 2012-05-18

BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE

Applicant Cliniqa Corporation

K number K121237

JJX 2012-05-10

ELECSYS LH CALCHECK 5

Applicant Roche Diagnostics

K number K121279

JJX 2012-05-10

COMPLETE D 25-OH VITAMIN D CONTROL

Applicant Quantimetrix Corp.

K number K113177

JJX 2012-05-09

LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L

K number K121084

JJX 2012-04-09

ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS

Applicant ACON Laboratories, Inc.

K number K112653

JJX 2012-02-14

IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...

K number K111938

JJX 2012-01-31

AUDIT MICROCV T-UPTAKE LINEARITY

Applicant Aalto Scientific, Ltd.

K number K112143

JJX 2012-01-30

GLUCOSE METER-CHECK SOLUTION FOR INFOPIA

Applicant Bionostics, Inc.

K number K113764

JJX 2012-01-27

VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT

Applicant Maine Standards Co.

K number K113524

JJX 2011-12-23

GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT

Applicant Bionostics, Inc.

K number K112352

JJX 2011-11-04

ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS

Applicant Beckman Coulter, Inc.

K number K112603

JJX 2011-10-18

ELECSYS T4 CALCHECK 5

Applicant Roche Diagnostics Corporation

K number K112528

JJX 2011-09-21

CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL

K number K110061

JJX 2011-09-19

GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE

Applicant Bionostics, Inc.

K number K112356

JJX 2011-09-14

ELECSYS MYOGLOBIN CALCHECK 5

Applicant Roche Diagnostics

K number K112113

JJX 2011-09-06

IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...

K number K111650

JJX 2011-08-25

ELECSYS N-MID OSTEOCALCIN CALCHECK 5

Applicant Roche Diagnostics

K number K112104

JJX 2011-07-21

ELECSYS T3 CALCHECK 5

Applicant Roche Diagnostics

K number K111552

JJX 2011-06-09

ELECSYS SHBG CALCHECK 5

Applicant Roche Diagnostics

K number K111349

JJX 2011-05-27

FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL

K number K110641

JJX 2011-05-12

ELECSYS PROLACTIN II CALCHECK 5

Applicant Roche Diagnostics

K number K110613

JJX 2011-05-12

DROPPER A1C DIABETES CONTROL

Applicant Quantimetrix Corp.

K number K103744

JJX 2011-04-28

IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)

K number K103683

JJX 2011-04-20

FDI GLUCOSE CONTROL SOLUTION FOR AVIVA

K number K110436

JJX 2011-03-16

IDS-ISYS IFG-I CONTROL SET

K number K110412

JJX 2011-02-10

LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION

Applicant Bionostics, Inc.

K number K103553

JJX 2011-01-25

FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE

K number K103450

JJX 2011-01-07

ELECSYS DHEA-S CALCHECK 5

Applicant Roche Diagnostics

K number K103402

JJX 2010-12-23

AUDIT MICROCV HS-CRP LINEARITY SET

Applicant Aalto Scientific, Ltd.

K number K101427

JJX 2010-12-23

AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5

Applicant Aalto Scientific, Ltd.

K number K100715

JJX 2010-12-06

PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH

Applicant Roche Diagnostics

K number K103099

JJX 2010-11-23

ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL

K number K102904

JJX 2010-11-18

ELECSYS PTH CALCHECK 5

Applicant Roche Diagnostics

K number K103162

JJX 2010-11-01

ELECSYS CA 125 II CALCHECK 5

Applicant Roche Diagnostics

K number K102086

JJX 2010-10-07

ELECSYS IGE CALCHECK 5

Applicant Roche Diagnostics

K number K102269

JJX 2010-10-05

ELECSYS CEA CALCHECK 5

Applicant Roche Diagnostics

K number K101856

JJX 2010-10-05

ELECSYS CA 19-9 CALCHECK 5

Applicant Roche Diagnostics Corp.

K number K101365

JJX 2010-09-24

FDI GLUCOSE CONTROL SOLUTIONS

K number K102260

JJX 2010-09-10

ELECSYS FERRITIN CALCHECK 5

Applicant Roche Diagnostics

K number K102267

JJX 2010-08-31

ELECSYS DIGOXIN CALCHECK 5

Applicant Roche Diagnostics

K number K102044

JJX 2010-07-29

FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION

Applicant Taidoc Technology Corporation

K number K093724

JJX 2010-06-11

ELECSYS INSULIN CALCHECK 5

Applicant Roche Diagnostics Corp.

K number K101075

JJX 2010-05-21

AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5

Applicant Aalto Scientific, Ltd.

K number K100750

JJX 2010-04-27

ELECSYS FOLATE III CALCHECK 5

Applicant Roche Diagnostics

K number K094031

JJX 2010-04-26

ELECSYS C-PEPTIDE CALCHECK 5

Applicant Roche Diagnostics

K number K100810

JJX 2010-04-26

SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER

Applicant Diazyme Laboratories

K number K092911

JJX 2010-04-15

ELECSYS TSH CALCHECK 5

Applicant Roche Diagnostics

K number K093836

JJX 2010-04-14

CONTREX PLUS LOW CONTROL SOLUTION

Applicant Apex BioTechnology Corp.

K number K100747

JJX 2010-04-01

ELECSYS TROPONIN I CALCHECK 5

Applicant Roche Diagnostics

K number K100594

JJX 2010-03-29

ELECSYS CK-MB CALCHECK 5

Applicant Roche Diagnostics

K number K093582

JJX 2010-03-19

ELECSYS TROPONIN T CALCHECK 5

Applicant Roche Diagnostics Corp.

K number K092848

JJX 2010-03-04

ELECSYS HCG STAT CALCHECK 5

Applicant Roche Diagnostics Corp.

K number K093700

JJX 2009-12-16

ELECSYS PROBNP II CALCHECK 5

Applicant Roche Diagnostics

K number K092169

JJX 2009-12-14

LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913

Applicant DiaSorin, Inc.

K number K093498

JJX 2009-12-03

MAS AND MINI-TROL PTH CONTROL

Applicant Microgenics Corporation

K number K092749

JJX 2009-11-20

ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL

K number K092993

JJX 2009-11-16

ELECSYS HCG+B CALCHECK 5

Applicant Roche Diagnostics

K number K092168

JJX 2009-11-10

ELECSYS TOXO IGG CALCHECK 5

Applicant Roche Diagnostics Corp.

K number K092888

JJX 2009-11-06

OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION

Applicant Bionostics, Inc.

K number K091914

JJX 2009-10-30

ELECSYS RUBELLA IGGA CALCHECK 5

Applicant Roche Diagnostics

K number K092585

JJX 2009-09-25

ELECYS ANTI-CCP CALCHECK

Applicant Roche Diagnostics Corp.

K number K091601

JJX 2009-09-09

LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603

Applicant DiaSorin, Inc.

K number K090104

JJX 2009-09-05

FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3

K number K092645

JJX 2009-08-14

ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS

K number K091123

JJX 2009-08-06

ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087

Applicant American Biological Technologies, Inc.

K number K091460

JJX 2009-05-27

ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089

Applicant American Biological Technologies, Inc.

K number K090943

JJX 2009-05-05

ELECSYS RUBELLA IGG CALCHECK

Applicant Roche Diagnostics

K number K090311