JJX · Single (Specified) Analyte Controls (Assayed And Unassayed)
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | JJX |
|---|---|
| Device Name | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Classification Rationale
Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Cleared Devices (493)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | Apr 4, 2017 | SESE |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics | Jan 12, 2017 | SESE |
| K162514 | Multichem A1c | Technopath Manufacturing | Oct 26, 2016 | SESE |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific, Ltd. | Aug 10, 2016 | SESE |
| K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin, Inc. | Jun 30, 2016 | SESE |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | Jun 30, 2016 | SESE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | May 17, 2016 | SESE |
| K152117 | Dropper hsCRP High Sensitivity CRP Control | Quantimetrix Corporation | Apr 21, 2016 | SESE |
| K151742 | Contour Next Control Solution | Bayer Healthcare | Sep 23, 2015 | SESE |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | Siemens Healthcare Diagnostics, Inc. | Jul 17, 2015 | SESE |
| K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | May 1, 2015 | SESE |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics | Apr 13, 2015 | SESE |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems , Ltd. | Mar 30, 2015 | SESE |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Feb 26, 2015 | SESE |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Feb 25, 2015 | SESE |
| K143680 | ADVIA Centaur IgE Master Curve Material | Siemens Healthcare Diagnostics, Inc. | Jan 27, 2015 | SESE |
| K143639 | IMMULITE 2000 CEA Calibration Verification Material | Siemens Healthcare Diagnostics | Jan 23, 2015 | SESE |
| K143571 | Audit MicroControls Linearity LQ Cystatin-C | Aalto Scientific, Ltd. | Jan 23, 2015 | SESE |
| K143504 | IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Jan 14, 2015 | SESE |
| K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Dec 24, 2014 | SESE |
| K143376 | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material | Siemens Healthcare Diagnostics, Inc. | Dec 23, 2014 | SESE |
| K143296 | AIA-PACK C-Peptide Control Set | Tosoh Bioscience, Inc. | Dec 16, 2014 | SESE |
| K143284 | Elecsys Estradiol III Calcheck | Roche Diagnostics | Dec 16, 2014 | SESE |
| K143194 | ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) | Siemens Healthcare Diagnostics, Inc. | Dec 5, 2014 | SESE |
| K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity | Aalto Scientific, Ltd. | Nov 21, 2014 | SESE |
| K142878 | IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Oct 30, 2014 | SESE |
| K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) | Siemens Healthcare Diagnostics, Inc. | Oct 29, 2014 | SESE |
| K142811 | IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) | Siemens Healthcare Diagnostics, Inc. | Oct 29, 2014 | SESE |
| K142127 | ELECSYS ESTRADIOL III CALCHECK 5 | Roche Diagnostics | Sep 5, 2014 | SESE |
| K141772 | IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | Aug 19, 2014 | SESE |
| K141444 | IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL | Siemens Healthcare Diagnostics, Inc. | Jul 9, 2014 | SESE |
| K133816 | IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | Jun 24, 2014 | SESE |
| K140818 | IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C | Siemens Healthcare Diagnostics, Inc. | May 1, 2014 | SESE |
| K140541 | IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C | Siemens Healthcare Diagnostics, Inc. | Apr 1, 2014 | SESE |
| K140505 | ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL | Siemens Healthcare Diagnostics, Inc. | Mar 31, 2014 | SESE |
| K140534 | ELECSYS PRECICONTROL TS | Roche Diagnostics | Mar 27, 2014 | SESE |
| K140267 | ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) | Siemens Healthcare Diagnostics, Inc. | Mar 10, 2014 | SESE |
| K140258 | IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | Mar 5, 2014 | SESE |
| K133550 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT | Maine Standards Company, LLC | Feb 5, 2014 | SESE |
| K133197 | FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE | Fujirebio Diagnostics,Inc. | Jan 17, 2014 | SESE |
| K132739 | IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | Jan 14, 2014 | SESE |
| K133284 | ELECSYS CK-MB CALCHECK 5 | Roche Diagnostics | Nov 22, 2013 | SESE |
| K133122 | IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) | Siemens Healthcare Diagnostics, Inc. | Oct 30, 2013 | SESE |
| K133124 | IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA | Siemens Healthcare Diagnostics, Inc. | Oct 25, 2013 | SESE |
| K133003 | RIGHTEST CONTROL SOLUTION | Bionime Corporation | Oct 24, 2013 | SESE |
| K133128 | IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION | Siemens Healthcare Diagnostics, Inc. | Oct 22, 2013 | SESE |
| K131662 | IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | Oct 10, 2013 | SESE |
| K132391 | IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL | Siemens Helathcare Diagnostics, Inc. | Sep 20, 2013 | SESE |
| K131536 | IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | Aug 12, 2013 | SESE |
| K131999 | HBA1C CONTROL, LEVEL 1 AND LEVEL 2 | Randox Laboratories, Ltd. | Jul 26, 2013 | SESE |
| K131776 | ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 | Randox Laboratories, Ltd. | Jul 18, 2013 | SESE |
| K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 | Maine Standards Co. | Jun 14, 2013 | SESE |
| K131136 | GLUCOSE METER-CHECK SOLUTION FOR TAIDOC | Bionostics, Inc. | May 31, 2013 | SESE |
| K130764 | AUDIT MICROCV VITAMIN D LINEARITY SET | Aalto Scientific, Ltd. | Apr 26, 2013 | SESE |
| K130157 | AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET | Aalto Scientific, Ltd. | Mar 19, 2013 | SESE |
| K122534 | IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | Mar 14, 2013 | SESE |
| K123851 | GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK | Bionostics, Inc. | Feb 14, 2013 | SESE |
| K123966 | GLUCOSE METER-CHECK SOLUTION FOR BAYER | Bionostics, Inc. | Jan 25, 2013 | SESE |
| K123612 | FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA | Fujirebio Diagnostics,Inc. | Jan 17, 2013 | SESE |
| K123798 | LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | Bio-Rad Laboratories | Jan 9, 2013 | SESE |
| K122242 | ELECSYS CA 15-3 II CALCHECK 5 | Roche Diagnostics | Dec 5, 2012 | SESE |
| K121895 | ELECSYS HSV-2 IGG IMMUNOASSAY | Roche Diagnostics | Aug 24, 2012 | SESE |
| K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS | Immunodiagnostic Systems , Ltd. | Aug 7, 2012 | SESE |
| K121746 | RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) | Randox Laboratories, Ltd. | Jul 11, 2012 | SESE |
| K121588 | RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 | Randox Laboratories, Ltd. | Jun 20, 2012 | SESE |
| K121534 | CONE-TROL HEMOGLOBIN A1C CONTROL SET | Cone Bioproducts | Jun 20, 2012 | SESE |
| K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE | Cliniqa Corporation | May 18, 2012 | SESE |
| K121279 | ELECSYS LH CALCHECK 5 | Roche Diagnostics | May 10, 2012 | SESE |
| K113177 | COMPLETE D 25-OH VITAMIN D CONTROL | Quantimetrix Corp. | May 10, 2012 | SESE |
| K121084 | LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L | Siemens Healthcare Diagnostics, Inc. | May 9, 2012 | SESE |
| K112653 | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS | ACON Laboratories, Inc. | Apr 9, 2012 | SESE |
| K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... | Immunodiagnostic Systems , Ltd. | Feb 14, 2012 | SESE |
| K112143 | AUDIT MICROCV T-UPTAKE LINEARITY | Aalto Scientific, Ltd. | Jan 31, 2012 | SESE |
| K113764 | GLUCOSE METER-CHECK SOLUTION FOR INFOPIA | Bionostics, Inc. | Jan 30, 2012 | SESE |
| K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT | Maine Standards Co. | Jan 27, 2012 | SESE |
| K112352 | GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT | Bionostics, Inc. | Dec 23, 2011 | SESE |
| K112603 | ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | Nov 4, 2011 | SESE |
| K112528 | ELECSYS T4 CALCHECK 5 | Roche Diagnostics Corporation | Oct 18, 2011 | SESE |
| K110061 | CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics | Sep 21, 2011 | SESE |
| K112356 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE | Bionostics, Inc. | Sep 19, 2011 | SESE |
| K112113 | ELECSYS MYOGLOBIN CALCHECK 5 | Roche Diagnostics | Sep 14, 2011 | SESE |
| K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... | Immunodiagnostic Systems , Ltd. | Sep 6, 2011 | SESE |
| K112104 | ELECSYS N-MID OSTEOCALCIN CALCHECK 5 | Roche Diagnostics | Aug 25, 2011 | SESE |
| K111552 | ELECSYS T3 CALCHECK 5 | Roche Diagnostics | Jul 21, 2011 | SESE |
| K111349 | ELECSYS SHBG CALCHECK 5 | Roche Diagnostics | Jun 9, 2011 | SESE |
| K110641 | FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL | Fujirebio Diagnostics,Inc. | May 27, 2011 | SESE |
| K110613 | ELECSYS PROLACTIN II CALCHECK 5 | Roche Diagnostics | May 12, 2011 | SESE |
| K103744 | DROPPER A1C DIABETES CONTROL | Quantimetrix Corp. | May 12, 2011 | SESE |
| K103683 | IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) | Siemens Healthcare Diagnostics | Apr 28, 2011 | SESE |
| K110436 | FDI GLUCOSE CONTROL SOLUTION FOR AVIVA | Fujirebio Diagnostics,Inc. | Apr 20, 2011 | SESE |
| K110412 | IDS-ISYS IFG-I CONTROL SET | Immunodiagnostic Systems , Ltd. | Mar 16, 2011 | SESE |
| K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION | Bionostics, Inc. | Feb 10, 2011 | SESE |
| K103450 | FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE | Fujirebio Diagnostics,Inc. | Jan 25, 2011 | SESE |
| K103402 | ELECSYS DHEA-S CALCHECK 5 | Roche Diagnostics | Jan 7, 2011 | SESE |
| K101427 | AUDIT MICROCV HS-CRP LINEARITY SET | Aalto Scientific, Ltd. | Dec 23, 2010 | SESE |
| K100715 | AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 | Aalto Scientific, Ltd. | Dec 23, 2010 | SESE |
| K103099 | PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH | Roche Diagnostics | Dec 6, 2010 | SESE |
| K102904 | ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL | Siemens Healthcare Diagnostics | Nov 23, 2010 | SESE |
| K103162 | ELECSYS PTH CALCHECK 5 | Roche Diagnostics | Nov 18, 2010 | SESE |
| K102086 | ELECSYS CA 125 II CALCHECK 5 | Roche Diagnostics | Nov 1, 2010 | SESE |
| K102269 | ELECSYS IGE CALCHECK 5 | Roche Diagnostics | Oct 7, 2010 | SESE |
| K101856 | ELECSYS CEA CALCHECK 5 | Roche Diagnostics | Oct 5, 2010 | SESE |
| K101365 | ELECSYS CA 19-9 CALCHECK 5 | Roche Diagnostics Corp. | Oct 5, 2010 | SESE |
| K102260 | FDI GLUCOSE CONTROL SOLUTIONS | Fujirebio Diagnostics,Inc. | Sep 24, 2010 | SESE |
| K102267 | ELECSYS FERRITIN CALCHECK 5 | Roche Diagnostics | Sep 10, 2010 | SESE |
| K102044 | ELECSYS DIGOXIN CALCHECK 5 | Roche Diagnostics | Aug 31, 2010 | SESE |
| K093724 | FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION | Taidoc Technology Corporation | Jul 29, 2010 | SESE |
| K101075 | ELECSYS INSULIN CALCHECK 5 | Roche Diagnostics Corp. | Jun 11, 2010 | SESE |
| K100750 | AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 | Aalto Scientific, Ltd. | May 21, 2010 | SESE |
| K094031 | ELECSYS FOLATE III CALCHECK 5 | Roche Diagnostics | Apr 27, 2010 | SESE |
| K100810 | ELECSYS C-PEPTIDE CALCHECK 5 | Roche Diagnostics | Apr 26, 2010 | SESE |
| K092911 | SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER | Diazyme Laboratories | Apr 26, 2010 | SESE |
| K093836 | ELECSYS TSH CALCHECK 5 | Roche Diagnostics | Apr 15, 2010 | SESE |
| K100747 | CONTREX PLUS LOW CONTROL SOLUTION | Apex BioTechnology Corp. | Apr 14, 2010 | SESE |
| K100594 | ELECSYS TROPONIN I CALCHECK 5 | Roche Diagnostics | Apr 1, 2010 | SESE |
| K093582 | ELECSYS CK-MB CALCHECK 5 | Roche Diagnostics | Mar 29, 2010 | SESE |
| K092848 | ELECSYS TROPONIN T CALCHECK 5 | Roche Diagnostics Corp. | Mar 19, 2010 | SESE |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Roche Diagnostics Corp. | Mar 4, 2010 | SESE |
| K092169 | ELECSYS PROBNP II CALCHECK 5 | Roche Diagnostics | Dec 16, 2009 | SESE |
| K093498 | LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 | DiaSorin, Inc. | Dec 14, 2009 | SESE |
| K092749 | MAS AND MINI-TROL PTH CONTROL | Microgenics Corporation | Dec 3, 2009 | SESE |
| K092993 | ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL | Siemens Healthcare Diagnostics | Nov 20, 2009 | SESE |
| K092168 | ELECSYS HCG+B CALCHECK 5 | Roche Diagnostics | Nov 16, 2009 | SESE |
| K092888 | ELECSYS TOXO IGG CALCHECK 5 | Roche Diagnostics Corp. | Nov 10, 2009 | SESE |
| K091914 | OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION | Bionostics, Inc. | Nov 6, 2009 | SESE |
| K092585 | ELECSYS RUBELLA IGGA CALCHECK 5 | Roche Diagnostics | Oct 30, 2009 | SESE |
| K091601 | ELECYS ANTI-CCP CALCHECK | Roche Diagnostics Corp. | Sep 25, 2009 | SESE |
| K090104 | LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 | DiaSorin, Inc. | Sep 9, 2009 | SESE |
| K092645 | FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 | Fujirebio Diagnostics,Inc. | Sep 5, 2009 | SESE |
| K091123 | ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS | Siemens Healthcare Diagnostics | Aug 14, 2009 | SESE |
| K091460 | ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 | American Biological Technologies, Inc. | Aug 6, 2009 | SESE |
| K090943 | ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 | American Biological Technologies, Inc. | May 27, 2009 | SESE |
| K090311 | ELECSYS RUBELLA IGG CALCHECK | Roche Diagnostics | May 5, 2009 | SESE |
| K090854 | ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 | American Biological Technologies, Inc. | Apr 16, 2009 | SESE |
| K083655 | ELECSYS TOXO IGG CALCHECK | Roche Diagnostics | Feb 12, 2009 | SESE |
| K083549 | ABT GLUCOSE CONTROL SOLUTION | American Biological Technologies, Inc. | Dec 22, 2008 | SESE |
| K081478 | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS | Bionostics, Inc. | Oct 6, 2008 | SESE |
| K082395 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 | Bionostics, Inc. | Sep 18, 2008 | SESE |
| K080643 | ELECSYS ANTI-TSHR CALCHECK | Roche Diagnostics | Aug 22, 2008 | SESE |
| K081915 | FDTX GLUCOSE CONTROL SOLUTION | Fujirebio Diagnostics Texas, Inc. | Aug 8, 2008 | SESE |
| K080273 | AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION | Fujirebio Diagnostics Texas, Inc. | Aug 8, 2008 | SESE |
| K081403 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK | Bionostics, Inc. | Jul 25, 2008 | SESE |
| K080147 | ELECSYS PROBNP II CALCHECK | Roche Diagnostics Corp. | Feb 27, 2008 | SESE |
| K071648 | EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS | Canterbury Scientific , Ltd. | Aug 22, 2007 | SESE |
| K071587 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY | Inverness Medical Innovations, Inc. | Jul 30, 2007 | SESE |
| K070506 | SMS MULTI GLUCOSE CONTROL, MODEL 2120049 | Medical Specialties Supply Co., Inc. | Apr 18, 2007 | SESE |
| K070649 | SMS GLUCOSE CONTROL, MODEL 2120061 | Spectrum Medical Supply, Inc. | Apr 12, 2007 | SESE |
| K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT | Qualigen, Inc. | Apr 2, 2007 | SESE |
| K063855 | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 | Liberty Healthcare Group, Inc. | Feb 1, 2007 | SESE |
| K062972 | PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS | Roche Diagnostics Corp. | Oct 13, 2006 | SESE |
| K062501 | VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 | Maine Standards Co. | Sep 29, 2006 | SESE |
| K060510 | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT | Drew Scientific , Ltd. | Jun 19, 2006 | SESE |
| K060706 | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION | Liberty Healthcare Group, Inc. | Apr 28, 2006 | SESE |
| K060570 | HEMOGLOBIN ALC CONTROL | Compass Bioscience | Apr 13, 2006 | SESE |
| K060215 | ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 | Eurotrol B.V. | Mar 24, 2006 | SESE |
| K060481 | LIBERTY GLUCOSE CONTROL SOLUTION | Liberty Healthcare Group, Inc. | Mar 9, 2006 | SESE |
| K060426 | LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 | Liberty Healthcare Group, Inc. | Mar 9, 2006 | SESE |
| K060133 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET | Inverness Medical Innovations, Inc. | Feb 16, 2006 | SESE |
| K060027 | ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) | Biokit, S.A. | Jan 26, 2006 | SESE |
| K053327 | OXICOM CONTROL | Bionostics, Inc. | Jan 26, 2006 | SESE |
| K052980 | LIBERTY GLUCOSE CONTROL, MODEL 2120031 | Liberty Healthcare Group, Inc. | Nov 30, 2005 | SESE |
| K053059 | ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK | Roche Diagnostics | Nov 28, 2005 | SESE |
| K052679 | CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E | Cliniqa Corporation | Nov 18, 2005 | SESE |
| K052010 | HBA1C LINEARITY SET | Cone Bioproducts | Oct 4, 2005 | SESE |
| K050983 | IRMA TRUPOINT CREATININE CONTROL KIT | International Technidyne Corporation | May 16, 2005 | SESE |
| K050961 | RNA1C CONTROL FOR NYCOCARD HBA1C | Bionostics, Inc. | May 13, 2005 | SESE |
| K050328 | PREGNANCY-SKREEN | Biochemical Diagnostic, Inc. | Mar 29, 2005 | SESE |
| K050100 | RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER | Bionostics, Inc. | Feb 25, 2005 | SESE |
| K043584 | LIQUICHEK BNP CONTROL | Bio-Rad Laboratories, Inc. | Feb 8, 2005 | SESE |
| K043320 | MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II | Roche Diagnostics Corp. | Dec 17, 2004 | SESE |
| K043070 | LIQUID STABLE HBA1C CONTROL | Canterbury Scientific , Ltd. | Dec 9, 2004 | SESE |
| K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL | Medical Analysis Systems, Inc. | Nov 5, 2004 | SESE |
| K042837 | LIQUICHEK ELEVATED CRP CONTROL | Bio-Rad | Nov 2, 2004 | SESE |
| K042448 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT | General Atomics | Oct 29, 2004 | SESE |
| K042303 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS | Ortho-Clinical Diagnostics | Sep 27, 2004 | SESE |
| K042080 | TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM | Home Diagnostics, Inc. | Aug 19, 2004 | SESE |
| K041687 | ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR | Abbott Laboratories | Aug 18, 2004 | SESE |
| K041898 | CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM | Cliniqa Corporation | Aug 16, 2004 | SESE |
| K041871 | INTERLAB MICROCAL SERUM CONTROLS | Trouble Shooter Consuling, Inc. | Aug 16, 2004 | SESE |
| K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H | Medical Analysis Systems, Inc. | Aug 16, 2004 | SESE |
| K040927 | LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS | Cliniqa Corporation | May 17, 2004 | SESE |
| K040918 | WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 | Wako Chemicals USA, Inc. | May 17, 2004 | SESE |
| K041016 | NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS | Nova Biomedical Corp. | May 7, 2004 | SESE |
| K040351 | RANDOX LIQUID CRP CONTROLS | Randox Laboratories, Ltd. | Mar 12, 2004 | SESE |
| K034048 | R&D GLU-LINE HEMATOLOGY CONTROL | R&D Systems, Inc. | Mar 10, 2004 | SESE |
| K040455 | LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS | Cliniqa Corporation | Mar 5, 2004 | SESE |
| K040025 | A1C-CELLULAR | Streck Laboratories, Inc. | Mar 2, 2004 | SESE |
| K040157 | ELECSYS C-PEPTIDE CALCHECK | Roche Diagnostics Corp. | Feb 25, 2004 | SESE |
| K030849 | AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 | N-Dia, Inc. | Feb 2, 2004 | SESE |
| K033433 | NOVA GLUCOSE CONTROL SOLUTIONS | Nova Biomedical Corp. | Jan 2, 2004 | SESE |
| K033127 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS | Ortho-Clinical Diagnostics | Oct 31, 2003 | SESE |
| K032993 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS | Ortho-Clinical Diagnostics, Inc. | Oct 31, 2003 | SESE |
| K032819 | GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM | Bionostics, Inc. | Oct 20, 2003 | SESE |
| K031873 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET | I-Stat Corporation | Oct 7, 2003 | SESE |
| K031990 | ELECSYS PRECICONTROL TROPONIN T | Roche Diagnostics Corp. | Aug 20, 2003 | SESE |
| K031698 | ELECYS SHBG CALCHECK | Roche Diagnostics Corp. | Aug 20, 2003 | SESE |
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL | Medical Analysis Systems, Inc. | Jul 16, 2003 | SESE |
| K030628 | SAS RSV CONTROL KIT | Sa Scientific, Inc. | Mar 17, 2003 | SESE |
| K030065 | WAKO NEFA LINEARITY SET | Wako Chemicals USA, Inc. | Feb 11, 2003 | SESE |
| K020883 | ELECSYS PROBNP CALCHECK | Roche Diagnostics Corp. | Nov 29, 2002 | SESE |
Top Applicants
- Roche Diagnostics — 35 clearances
- Siemens Healthcare Diagnostics, Inc. — 27 clearances
- Boehringer Mannheim Corp. — 24 clearances
- Roche Diagnostics Corp. — 22 clearances
- Bionostics, Inc. — 22 clearances
