FDA Product Code
FDA Product Code JJX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 493 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K102269 | ELECSYS IGE CALCHECK 5 | Roche Diagnostics | 2010-10-07 | Traditional | PDF ↗ |
| K101856 | ELECSYS CEA CALCHECK 5 | Roche Diagnostics | 2010-10-05 | Traditional | PDF ↗ |
| K101365 | ELECSYS CA 19-9 CALCHECK 5 | Roche Diagnostics Corp. | 2010-10-05 | Traditional | PDF ↗ |
| K102260 | FDI GLUCOSE CONTROL SOLUTIONS | Fujirebio Diagnostics,Inc. | 2010-09-24 | Traditional | PDF ↗ |
| K102267 | ELECSYS FERRITIN CALCHECK 5 | Roche Diagnostics | 2010-09-10 | Traditional | PDF ↗ |
| K102044 | ELECSYS DIGOXIN CALCHECK 5 | Roche Diagnostics | 2010-08-31 | Traditional | PDF ↗ |
| K093724 | FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION | Taidoc Technology Corporation | 2010-07-29 | Traditional | PDF ↗ |
| K101075 | ELECSYS INSULIN CALCHECK 5 | Roche Diagnostics Corp. | 2010-06-11 | Traditional | PDF ↗ |
| K100750 | AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 | Aalto Scientific, Ltd. | 2010-05-21 | Traditional | PDF ↗ |
| K094031 | ELECSYS FOLATE III CALCHECK 5 | Roche Diagnostics | 2010-04-27 | Traditional | PDF ↗ |
| K100810 | ELECSYS C-PEPTIDE CALCHECK 5 | Roche Diagnostics | 2010-04-26 | Traditional | PDF ↗ |
| K092911 | SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER | Diazyme Laboratories | 2010-04-26 | Traditional | PDF ↗ |
| K093836 | ELECSYS TSH CALCHECK 5 | Roche Diagnostics | 2010-04-15 | Traditional | PDF ↗ |
| K100747 | CONTREX PLUS LOW CONTROL SOLUTION | Apex BioTechnology Corp. | 2010-04-14 | Traditional | PDF ↗ |
| K100594 | ELECSYS TROPONIN I CALCHECK 5 | Roche Diagnostics | 2010-04-01 | Traditional | PDF ↗ |
| K093582 | ELECSYS CK-MB CALCHECK 5 | Roche Diagnostics | 2010-03-29 | Traditional | PDF ↗ |
| K092848 | ELECSYS TROPONIN T CALCHECK 5 | Roche Diagnostics Corp. | 2010-03-19 | Traditional | PDF ↗ |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Roche Diagnostics Corp. | 2010-03-04 | Traditional | PDF ↗ |
| K092169 | ELECSYS PROBNP II CALCHECK 5 | Roche Diagnostics | 2009-12-16 | Traditional | PDF ↗ |
| K093498 | LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 | DiaSorin, Inc. | 2009-12-14 | Traditional | PDF ↗ |
| K092749 | MAS AND MINI-TROL PTH CONTROL | Microgenics Corporation | 2009-12-03 | Traditional | PDF ↗ |
| K092993 | ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL | Siemens Healthcare Diagnostics | 2009-11-20 | Abbreviated | PDF ↗ |
| K092168 | ELECSYS HCG+B CALCHECK 5 | Roche Diagnostics | 2009-11-16 | Traditional | PDF ↗ |
| K092888 | ELECSYS TOXO IGG CALCHECK 5 | Roche Diagnostics Corp. | 2009-11-10 | Traditional | PDF ↗ |
| K091914 | OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION | Bionostics, Inc. | 2009-11-06 | Traditional | PDF ↗ |
| K092585 | ELECSYS RUBELLA IGGA CALCHECK 5 | Roche Diagnostics | 2009-10-30 | Traditional | PDF ↗ |
| K091601 | ELECYS ANTI-CCP CALCHECK | Roche Diagnostics Corp. | 2009-09-25 | Traditional | PDF ↗ |
| K090104 | LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 | DiaSorin, Inc. | 2009-09-09 | Traditional | PDF ↗ |
| K092645 | FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 | Fujirebio Diagnostics,Inc. | 2009-09-05 | Traditional | PDF ↗ |
| K091123 | ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS | Siemens Healthcare Diagnostics | 2009-08-14 | Abbreviated | PDF ↗ |
| K091460 | ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 | American Biological Technologies, Inc. | 2009-08-06 | Traditional | PDF ↗ |
| K090943 | ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 | American Biological Technologies, Inc. | 2009-05-27 | Traditional | PDF ↗ |
| K090311 | ELECSYS RUBELLA IGG CALCHECK | Roche Diagnostics | 2009-05-05 | Traditional | PDF ↗ |
| K090854 | ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 | American Biological Technologies, Inc. | 2009-04-16 | Traditional | PDF ↗ |
| K083655 | ELECSYS TOXO IGG CALCHECK | Roche Diagnostics | 2009-02-12 | Traditional | PDF ↗ |
| K083549 | ABT GLUCOSE CONTROL SOLUTION | American Biological Technologies, Inc. | 2008-12-22 | Traditional | PDF ↗ |
| K081478 | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS | Bionostics, Inc. | 2008-10-06 | Traditional | PDF ↗ |
| K082395 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 | Bionostics, Inc. | 2008-09-18 | Traditional | PDF ↗ |
| K080643 | ELECSYS ANTI-TSHR CALCHECK | Roche Diagnostics | 2008-08-22 | Traditional | PDF ↗ |
| K080273 | AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K081915 | FDTX GLUCOSE CONTROL SOLUTION | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K081403 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK | Bionostics, Inc. | 2008-07-25 | Traditional | PDF ↗ |
| K080147 | ELECSYS PROBNP II CALCHECK | Roche Diagnostics Corp. | 2008-02-27 | Traditional | PDF ↗ |
| K071648 | EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS | Canterbury Scientific , Ltd. | 2007-08-22 | Traditional | PDF ↗ |
| K071587 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY | Inverness Medical Innovations, Inc. | 2007-07-30 | Special | PDF ↗ |
| K070506 | SMS MULTI GLUCOSE CONTROL, MODEL 2120049 | Medical Specialties Supply Co., Inc. | 2007-04-18 | Traditional | PDF ↗ |
| K070649 | SMS GLUCOSE CONTROL, MODEL 2120061 | Spectrum Medical Supply, Inc. | 2007-04-12 | Traditional | PDF ↗ |
| K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT | Qualigen, Inc. | 2007-04-02 | Abbreviated | PDF ↗ |
| K063855 | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 | Liberty Healthcare Group, Inc. | 2007-02-01 | Traditional | PDF ↗ |
| K062972 | PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS | Roche Diagnostics Corp. | 2006-10-13 | Special | PDF ↗ |
| K062501 | VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 | Maine Standards Co. | 2006-09-29 | Traditional | PDF ↗ |
| K060510 | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT | Drew Scientific , Ltd. | 2006-06-19 | Traditional | PDF ↗ |
| K060706 | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION | Liberty Healthcare Group, Inc. | 2006-04-28 | Traditional | PDF ↗ |
| K060570 | HEMOGLOBIN ALC CONTROL | Compass Bioscience | 2006-04-13 | Traditional | PDF ↗ |
| K060215 | ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 | Eurotrol B.V. | 2006-03-24 | Traditional | PDF ↗ |
| K060481 | LIBERTY GLUCOSE CONTROL SOLUTION | Liberty Healthcare Group, Inc. | 2006-03-09 | Traditional | PDF ↗ |
| K060426 | LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 | Liberty Healthcare Group, Inc. | 2006-03-09 | Traditional | PDF ↗ |
| K060133 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET | Inverness Medical Innovations, Inc. | 2006-02-16 | Traditional | PDF ↗ |
| K053327 | OXICOM CONTROL | Bionostics, Inc. | 2006-01-26 | Traditional | PDF ↗ |
| K060027 | ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) | Biokit, S.A. | 2006-01-26 | Traditional | PDF ↗ |
| K052980 | LIBERTY GLUCOSE CONTROL, MODEL 2120031 | Liberty Healthcare Group, Inc. | 2005-11-30 | Traditional | PDF ↗ |
| K053059 | ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK | Roche Diagnostics | 2005-11-28 | Special | PDF ↗ |
| K052679 | CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E | Cliniqa Corporation | 2005-11-18 | Traditional | PDF ↗ |
| K052010 | HBA1C LINEARITY SET | Cone Bioproducts | 2005-10-04 | Traditional | PDF ↗ |
| K050983 | IRMA TRUPOINT CREATININE CONTROL KIT | International Technidyne Corporation | 2005-05-16 | Traditional | PDF ↗ |
| K050961 | RNA1C CONTROL FOR NYCOCARD HBA1C | Bionostics, Inc. | 2005-05-13 | Traditional | PDF ↗ |
| K050328 | PREGNANCY-SKREEN | Biochemical Diagnostic, Inc. | 2005-03-29 | Traditional | PDF ↗ |
| K050100 | RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER | Bionostics, Inc. | 2005-02-25 | Traditional | PDF ↗ |
| K043584 | LIQUICHEK BNP CONTROL | Bio-Rad Laboratories, Inc. | 2005-02-08 | Traditional | PDF ↗ |
| K043320 | MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II | Roche Diagnostics Corp. | 2004-12-17 | Special | PDF ↗ |
| K043070 | LIQUID STABLE HBA1C CONTROL | Canterbury Scientific , Ltd. | 2004-12-09 | Traditional | PDF ↗ |
| K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL | Medical Analysis Systems, Inc. | 2004-11-05 | Traditional | PDF ↗ |
| K042837 | LIQUICHEK ELEVATED CRP CONTROL | Bio-Rad | 2004-11-02 | Traditional | PDF ↗ |
| K042448 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT | General Atomics | 2004-10-29 | Traditional | PDF ↗ |
| K042303 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS | Ortho-Clinical Diagnostics | 2004-09-27 | Traditional | PDF ↗ |
| K042080 | TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM | Home Diagnostics, Inc. | 2004-08-19 | Special | PDF ↗ |
| K041687 | ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR | Abbott Laboratories | 2004-08-18 | Abbreviated | PDF ↗ |
| K041898 | CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM | Cliniqa Corporation | 2004-08-16 | Traditional | PDF ↗ |
| K041871 | INTERLAB MICROCAL SERUM CONTROLS | Trouble Shooter Consuling, Inc. | 2004-08-16 | Traditional | PDF ↗ |
| K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H | Medical Analysis Systems, Inc. | 2004-08-16 | Traditional | PDF ↗ |
| K040927 | LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS | Cliniqa Corporation | 2004-05-17 | Traditional | PDF ↗ |
| K040918 | WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 | Wako Chemicals USA, Inc. | 2004-05-17 | Traditional | PDF ↗ |
| K041016 | NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS | Nova Biomedical Corp. | 2004-05-07 | Traditional | PDF ↗ |
| K040351 | RANDOX LIQUID CRP CONTROLS | Randox Laboratories, Ltd. | 2004-03-12 | Traditional | PDF ↗ |
| K034048 | R&D GLU-LINE HEMATOLOGY CONTROL | R&D Systems, Inc. | 2004-03-10 | Traditional | PDF ↗ |
| K040455 | LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS | Cliniqa Corporation | 2004-03-05 | Traditional | PDF ↗ |
| K040025 | A1C-CELLULAR | Streck Laboratories, Inc. | 2004-03-02 | Traditional | PDF ↗ |
| K040157 | ELECSYS C-PEPTIDE CALCHECK | Roche Diagnostics Corp. | 2004-02-25 | Traditional | PDF ↗ |
| K030849 | AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 | N-Dia, Inc. | 2004-02-02 | Traditional | PDF ↗ |
| K033433 | NOVA GLUCOSE CONTROL SOLUTIONS | Nova Biomedical Corp. | 2004-01-02 | Traditional | PDF ↗ |
| K033127 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS | Ortho-Clinical Diagnostics | 2003-10-31 | Traditional | PDF ↗ |
| K032993 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS | Ortho-Clinical Diagnostics, Inc. | 2003-10-31 | Traditional | PDF ↗ |
| K032819 | GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM | Bionostics, Inc. | 2003-10-20 | Traditional | PDF ↗ |
| K031873 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET | I-Stat Corporation | 2003-10-07 | Traditional | PDF ↗ |
| K031990 | ELECSYS PRECICONTROL TROPONIN T | Roche Diagnostics Corp. | 2003-08-20 | Traditional | PDF ↗ |
| K031698 | ELECYS SHBG CALCHECK | Roche Diagnostics Corp. | 2003-08-20 | Traditional | PDF ↗ |
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL | Medical Analysis Systems, Inc. | 2003-07-16 | Traditional | PDF ↗ |
| K030628 | SAS RSV CONTROL KIT | Sa Scientific, Inc. | 2003-03-17 | Traditional | PDF ↗ |
| K030065 | WAKO NEFA LINEARITY SET | Wako Chemicals USA, Inc. | 2003-02-11 | Traditional | PDF ↗ |
| K020883 | ELECSYS PROBNP CALCHECK | Roche Diagnostics Corp. | 2002-11-29 | Traditional | PDF ↗ |
Product code JJX · Class I · Clinical Chemistry. Data: openFDA.