meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
46
Latest Decision
2008-03-26

Clearances · page 20 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K073699 MCT-DIABETES Mycare Team, Inc. NBW Class II 2008-03-26
K072441 EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM Tyson Bioresearch, Inc. NBW Class II 2008-03-25
K072369 EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM Hmd Biomedical, LLC NBW Class II 2008-03-21
K080166 ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 Beckman Coulter, Inc. JIT Class II 2008-03-19
K071525 ACTIVATED ASPARTATE AMINOTRANSFERASE Abbott Laboratories CIT Class II 2008-03-19
K073604 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD Dade Behring, Inc. CEC Class II 2008-03-13
K073506 LUMINEX LX 100/200 INSTRUMENT Luminex Corp. NSU Class II 2008-03-07
K073488 DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX Diazyme Laboratories MSJ Class I 2008-03-07
K073118 PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM Diagnostic Devices, Inc. NBW Class II 2008-03-05
K071779 ABX PENTRA URINE CAL Horiba Abx JIX Class II 2008-03-05
K073119 CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2008-03-03
K073091 VIDAS NT-PROBNP ASSAY, MODEL: 30 449 bioMerieux, Inc. NBC Class II 2008-02-29
K072274 MAJOR III BLOOD GLUCOSE MONITORING SYSTEM Bestgen Biotech Corp. NBW Class II 2008-02-29
K073355 CALCIUM, SCAL, NORTROL, ABTROL Thermofisher Scientific OY CJY Class II 2008-02-28
K073191 ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL Thermofisher Scientific OY CJE Class II 2008-02-28
K072054 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 Bionime Corporation NBW Class II 2008-02-28
K080147 ELECSYS PROBNP II CALCHECK Roche Diagnostics Corp. JJX Class I 2008-02-27
K073072 DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B Dade Behring, Inc. JHM Class I 2008-02-21
K072249 EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT Medica Corp. CHH Class I 2008-02-20
K072409 AFINION ACR AND ACR CONTROL Axis-Shield Poc AS JFY Class II 2008-02-12
K072189 PATHFAST NTPROBNP AND D-DIMER TESTS Mitsubishi Kagaku Iatron NBC Class II 2008-02-05
K072437 ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET Roche Diagnostics NBC Class II 2008-02-05
K072270 DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) Diazyme Laboratories NDY Class II 2008-02-01
K072018 BS-200 CHEMISTRY ANALYZER, MODE BS-200 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. CFR Class II 2008-02-01
K073573 WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM Agamatrix NBW Class II 2008-01-30
K062534 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE Drg Intl., Inc. JLX Class I 2008-01-29
K073080 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 Bio-Rad Laboratories JJY Class I 2008-01-24
K072166 CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER The Binding Site NDY Class II 2008-01-24
K072523 DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS General Atomics LBR Class I 2008-01-22
K072395 DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS Diazyme Laboratories LBS Class I 2008-01-03
K073055 DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 Dade Behring, Inc. JFY Class II 2008-01-03
K072836 CHOLESTRAK HDL CHOLESTEROL HOME TEST Accutech, LLC LBS Class I 2007-12-27
K072784 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2007-12-21
K072640 IRISPEC,CA/CB/CC Iris Diagnostics JJW Class I 2007-12-21
K071706 ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) Clinical Data, Inc. LBS Class I 2007-12-20
K071930 ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C Blue Cross Bio-Medical Co., Ltd. LCX Class II 2007-12-18
K063243 VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 bioMerieux, Inc. MMI Class II 2007-12-14
K072717 DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 Dade Behring, Inc. JIT Class II 2007-12-12
K072835 LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK Bio-Rad, Diagnostics Grp. JJY Class I 2007-12-11
K072892 TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 Biosite Incorporated JJY Class I 2007-12-07
K063845 ADVIA CHEMISTRY TOTAL BILIRUBIN_2 Bayer Healthcare, LLC JFM Class II 2007-12-07
K073157 VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc. CEM Class II 2007-12-07
K072264 FASTPACK HCG IMMUNOASSAY Qualigen, Inc. JHI Class II 2007-12-06
K070757 MICROPROTEIN REAGENT SET Pointe Scientific, Inc., JGP Class II 2007-12-04
K070053 EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 Eps Bio Technology Corp. NBW Class II 2007-12-03
K070824 CREATININE (ENZYMATIC) Thermofisher Scientific OY JFY Class II 2007-12-03
K072783 SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH Smiths Medical Asd, Inc. JKA Class II 2007-11-30
K072115 ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H Horiba Abx CGX Class II 2007-11-30
K071224 DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR Dade Behring, Inc. CDD Class II 2007-11-13
K063852 ACCESSA CHOLESTEROL PANEL Home Access Health Corp. JKA Class II 2007-11-09
K071388 GENTIAN CYSTATIN C IMMUNOASSAY Gentian AS NDY Class II 2007-11-06
K070984 THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS Abbott Diabetes Care, Inc. LFR Class II 2007-11-01
K071493 CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 Taidoc Technology Corporation NBW Class II 2007-10-26
K070484 QUANTRX FEMALE FERTILITY TEST Quantrx Biomedical Corporation NGA Class I 2007-10-22
K072638 ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 Roche Diagnostics Corp. JGQ Class II 2007-10-19
K062932 AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER Ahlstrom Mount Holly Springs, LLC JKA Class II 2007-10-19
K072435 DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H Dade Behring, Inc. JIX Class II 2007-10-17
K071100 AMNISCREEN HOME DETECTION LINER KIT Common Sense , Ltd. CEN Class I 2007-10-15
K071593 PTS PANELS CHOL+HDL PANEL TEST STRIPS Polymer Technology Systems, Inc. CHH Class I 2007-10-15
K070146 ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP Horiba Abx CDQ Class II 2007-10-12
K070597 VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST Nanosphere, Inc. NSU Class II 2007-10-11
K071934 MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT Biomet Manufacturing Corp JQC Class I 2007-10-11
K072204 ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS Siemens Medical Solutions Diagnostics JIX Class II 2007-10-05
K071340 CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL Thermofisher Scientific OY KHS Class II 2007-10-05
K070788 ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics NHG Class II 2007-10-05
K072543 ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2007-10-05
K071580 AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL Thermofisher Scientific OY CIT Class II 2007-10-03
K072039 ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F Taidoc Technology Corporation NBW Class II 2007-10-03
K071480 LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 DiaSorin, Inc. MRG Class II 2007-10-01
K072413 MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM Agamatrix NBW Class II 2007-09-27
K071346 IMMULISA INTRINSIC FACTOR ANTIBODY ELISA Immco Diagnostics, Inc. LIG Class II 2007-09-24
K072443 VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY Ortho-Clinical Diagnostics, Inc. CJY Class II 2007-09-24
K072440 VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) Ortho-Clinical Diagnostics, Inc. CJY Class II 2007-09-20
K072489 REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2007-09-20
K071971 DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL Diazyme Laboratories LPS Class II 2007-09-17
K072246 VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 Maine Standards Co. JJY Class I 2007-09-14
K071239 TOTAL PROTEIN URINE/CSF GEN.3 Roche Diagnostics JGQ Class II 2007-09-14
K070640 ARCHITECT STAT TROPONIN-1; MYOGLOBIN Fisher Diagnostics MMI Class II 2007-09-13
K071980 DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H Dade Behring, Inc. JJY Class I 2007-09-11
K071507 PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS Polymer Technology Systems, Inc. NBW Class II 2007-09-10
K070531 ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER Thermo Fisher Scientific CGZ Class II 2007-09-04
K070057 EASYRA CLINICAL CHEMISTRY ANALYZER Medica Corp. CGA Class II 2007-08-30
K071648 EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS Canterbury Scientific , Ltd. JJX Class I 2007-08-22
K070708 OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 Olympus Life & Material Science Europa GmbH (Irish CEC Class II 2007-08-21
K071834 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM Dade Behring, Inc. NBC Class II 2007-08-17
K063771 GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM Arkray Factory USA, Inc. NBW Class II 2007-08-09
K071039 MISSION OLYMPUS AU ISE CALIBRATORS Diamond Diagnostics, Inc. JIT Class II 2007-08-08
K071767 DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A Dade Behring, Inc. NBC Class II 2007-08-04
K070727 ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Siemens Medical Solutions Diagnostics JFY Class II 2007-08-03
K070820 ARCHITECT TACROLIMUS: MODEL 1L77 Fujirebio Diagnostics,Inc. MLM Class II 2007-08-01
K071211 COBAS C 111 ANALYZER Roche Diagnostics CIT Class II 2007-07-30
K070929 ACON U120 URINE ANALYZER, MODEL U111-101 ACON Laboratories, Inc. KQO Class I 2007-07-30
K071587 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY Inverness Medical Innovations, Inc. JJX Class I 2007-07-30
K062703 ONE STEP HCG PREGNANCY TEST Ai DE Diagnostic Co., Ltd. LCX Class II 2007-07-23
K071393 JAZZ BLOOD GLUCOSE MONITORING SYSTEM Agamatrix NBW Class II 2007-07-20
K071801 VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 Ortho-Clinical Diagnostics, Inc. JIX Class II 2007-07-20
K070704 TRILOGY ANALYZER Drew Scientific, Inc. CGA Class II 2007-07-13
K062118 POINTE 360 Pointe Scientific, Inc., CFR Class II 2007-07-13
K070709 ROCHE ELECSYS PTH TEST SYSTEM Roche Diagnostics Corp. CEW Class II 2007-07-13
K070960 NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM Nova Biomedical Corp. CGA Class II 2007-07-11

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.