Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 39
- Latest Decision
- 2014-11-19
Clearances · page 10 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K133303 | PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device | Bio-Analysis, Inc. | JKA | Class II | 2014-11-19 |
| K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT | Siemens Healthcare Diagnostics | KQO | Class I | 2014-11-17 |
| K132691 | ABL90 FLEX | Radiometer Medical Aps | MQM | Class I | 2014-11-13 |
| K133175 | DRAEGER JAUNDICE METER JM-105 | Draeger Medical Systems, Inc. | MQM | Class I | 2014-11-13 |
| K142878 | IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-10-30 |
| 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. | JJX | Class I | 2014-10-29 |
| K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-10-29 |
| K133849 | VANTERA CLINICAL ANALYZER | Liposcience | NSU | Class II | 2014-10-22 |
| K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) | Nova Biomedical Corporation | CHL | Class II | 2014-10-17 |
| K141426 | ELECSYS FOLATE III | Roche Diagnostics | CGN | Class II | 2014-10-17 |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System | Polymer Technology Systems, Inc. | CGA | Class II | 2014-10-02 |
| K140371 | FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) | Abbott Diabetes Care, Inc. | NBW | Class II | 2014-09-30 |
| K141829 | GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | NBW | Class II | 2014-09-24 |
| K132121 | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | PZI | Class II | 2014-09-24 |
| K131173 | FIA Blood Glucose Monitoring System (G2) | Hmd Biomedical, Inc. | NBW | Class II | 2014-09-18 |
| K142181 | RANDOX ALDOLASE CALIBRATION SERUM | Randox Laboratories Limited | JIT | Class II | 2014-09-18 |
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | Arkray Factory, Inc. | CGA | Class II | 2014-09-17 |
| K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents | Beckman Coulter, Inc. | CDD | Class II | 2014-09-16 |
| K133584 | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM | Eoshealth, Inc. | CGA | Class II | 2014-09-08 |
| K142035 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory, Inc. | NBW | Class II | 2014-09-05 |
| DEN130031 | NEPHROCHECK TEST SYSTEM | Astute Medical, Inc. | PIG | Class II | 2014-09-05 |
| K142127 | ELECSYS ESTRADIOL III CALCHECK 5 | Roche Diagnostics | JJX | Class I | 2014-09-05 |
| K140690 | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CDQ | Class II | 2014-09-02 |
| K133741 | ACCU-CHEK Performa Blood Glucose Monitoring System | Roche Diagnostics | NBW | Class II | 2014-08-29 |
| K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | Bionime Corporation | NBW | Class II | 2014-08-22 |
| K141772 | IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-08-19 |
| DEN140016 | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE | Dexcom, Inc. | PHV | Class I | 2014-08-19 |
| K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | NBW | Class II | 2014-08-14 |
| K142021 | Elecsys Estradiol III CalSet | Roche Diagnostics | JIT | Class II | 2014-08-12 |
| K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | Diamond Diagnostics, Inc. | JIT | Class II | 2014-08-08 |
| K131230 | GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION | Philosys, Inc. | NBW | Class II | 2014-08-04 |
| K140100 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | Nipro Diagnostics, Inc. | NBW | Class II | 2014-08-01 |
| K141728 | ACE CALIBRATOR | SENTINEL CH. SpA | JIT | Class II | 2014-07-28 |
| K133156 | ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA | Siemens Healthcare Diagnostics, Inc. | MRG | Class II | 2014-07-24 |
| K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | Elitechgroup | JHW | Class II | 2014-07-18 |
| K141143 | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | Roche Diagnostics | NDY | Class II | 2014-07-17 |
| K133676 | ABX PENTRA MICRO ALB CONTROL L/H | HORIBA ABX SAS | JJY | Class I | 2014-07-11 |
| K141388 | SYSTEM CALIBRATER | Beckman Coulter Ireland, Inc. | JIX | Class II | 2014-07-11 |
| K141444 | IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-07-09 |
| K140141 | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | NBW | Class II | 2014-07-03 |
| K141374 | BICARBONATE CALIBRATOR | Beckman Coulter Ireland, Inc. | JIT | Class II | 2014-06-30 |
| K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory, Inc. | CGA | Class II | 2014-06-30 |
| K133260 | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM | Tianjin Empecs Medical Device Co., Ltd. | NBW | Class II | 2014-06-27 |
| K132180 | IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM | Ideal Life, Inc. | NBW | Class II | 2014-06-25 |
| K133816 | IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-06-24 |
| K141073 | LIQUICHEK TUMOR MARKER CONTROL | Bio-Rad Laboratories | JJY | Class I | 2014-06-23 |
| K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER | Bayer Healthcare, LLC | NBW | Class II | 2014-06-23 |
| K140112 | CA 125 II CALSET II | Roche Diagnostics | JIT | Class II | 2014-06-06 |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | Teco Diagnostics | JIL | Class II | 2014-05-29 |
| K141220 | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE | Thermo Fisher Scientific (Life Technologies Holdin | NSU | Class II | 2014-05-22 |
| K133790 | IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM | Andon Health Co, Ltd. | NBW | Class II | 2014-05-22 |
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL | Randox Laboratories Limited | JJY | Class I | 2014-05-22 |
| K140373 | ISE INDIRECT NA, K, C1 FOR GEN 2 | Roche Diagnostics | JGS | Class II | 2014-05-22 |
| K140447 | BD VIPER LT SYSTEM | Becton, Dickinson and Company | OOI | Class II | 2014-05-20 |
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | Carolina Liquid Chemistries Corp. | JJE | Class I | 2014-05-16 |
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | Jas Diagnostics, Inc. | JJE | Class I | 2014-05-15 |
| K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL | Medica Corporation | JHY | Class II | 2014-05-13 |
| K140404 | ELECSYS CK-MB STAT IMMUNOASSAY | Roche Diagnostics | JHY | Class II | 2014-05-08 |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | Carolina Liquid Chemistries Corp. | LBS | Class I | 2014-05-08 |
| K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | Bio-Rad Laboratories | JJY | Class I | 2014-05-06 |
| K140818 | IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-05-01 |
| K133862 | ACCU-CHEK AVIVA PLUS SYSTEM | Roche Diagnostics Corporation | NBW | Class II | 2014-04-29 |
| K133652 | GSP NEONATAL TOTAL GALACTOSE KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | JIA | Class I | 2014-04-28 |
| K133537 | EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | LFR | Class II | 2014-04-28 |
| K140764 | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK | Bio-Rad Laboratories | JJY | Class I | 2014-04-25 |
| K134013 | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO | Bio-Rad Laboratories | JJY | Class I | 2014-04-24 |
| K132406 | ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | NBW | Class II | 2014-04-18 |
| K133522 | RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM | Bionime Coporation | NBW | Class II | 2014-04-17 |
| K131189 | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | Beckman Coulter, Inc. | CFR | Class II | 2014-04-17 |
| K133389 | EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | NBW | Class II | 2014-04-15 |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | Tosoh Bioscience, Inc. | JIT | Class II | 2014-04-10 |
| K133045 | ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | NBW | Class II | 2014-04-10 |
| K130456 | WUNDER PREGNANCY TEST | James Nguyen | JHI | Class II | 2014-04-08 |
| K140541 | IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-04-01 |
| K140505 | ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-03-31 |
| K140534 | ELECSYS PRECICONTROL TS | Roche Diagnostics | JJX | Class I | 2014-03-27 |
| K130603 | PATHFAST CTNL CALIBRATORS | Mitsubishi Chemical Medience Corporation | JIT | Class II | 2014-03-27 |
| K131703 | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM | Nova Biomedical Corporation | CHL | Class II | 2014-03-25 |
| K140393 | RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 | Randox Laboratories Limited | JJY | Class I | 2014-03-25 |
| K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | Axis-Shield Poc AS | CHH | Class I | 2014-03-21 |
| K133410 | DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET | Diazyme Laboratories | MRG | Class II | 2014-03-14 |
| K131928 | FREND TSH (REAGENT CARTRIDGE) | Nanoentek USA, Inc. | JLW | Class II | 2014-03-14 |
| K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | Hitachi Chemical Diagnostics, Inc. | KHS | Class II | 2014-03-11 |
| K140267 | ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-03-10 |
| K131750 | AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | CGA | Class II | 2014-03-06 |
| K140258 | IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL | Siemens Healthcare Diagnostics, Inc. | JJX | Class I | 2014-03-05 |
| K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS | Abbott Laboratories | PDJ | Class II | 2014-02-28 |
| K131727 | CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | LFR | Class II | 2014-02-28 |
| K133647 | EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | NBW | Class II | 2014-02-27 |
| K133491 | ADVIA CENTAUR TESTOSTERONE (TSTO) | Siemens Healthcare Diagnostics, Inc. | CDZ | Class I | 2014-02-21 |
| K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | Biotest Medical Corp. | NBW | Class II | 2014-02-21 |
| K133601 | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics, Inc. | CEW | Class II | 2014-02-05 |
| K133550 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT | Maine Standards Company, LLC | JJX | Class I | 2014-02-05 |
| K131444 | UA-CELLULAR COMPLETE | Streck | JJW | Class I | 2014-01-29 |
| K132638 | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | CGX | Class II | 2014-01-27 |
| K131244 | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET | Roche Diagnostics | CEC | Class II | 2014-01-27 |
| K133728 | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | CGX | Class II | 2014-01-24 |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | Tosoh Bioscience, Inc. | PDJ | Class II | 2014-01-23 |
| K133960 | LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL | Bio-Rad Laboratories | JJY | Class I | 2014-01-22 |
| K123517 | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM | Sd Biosensor | NBW | Class II | 2014-01-17 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.