meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
45
Latest Decision
2006-12-15

Clearances · page 22 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K063591 VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 Ortho-Clinical Diagnostics, Inc. JFY Class II 2006-12-15
K062770 COPILOT HEALTH MANAGEMENT SYSTEM Abbott Diabetes Care, Inc. NBW Class II 2006-12-14
K052719 URITEST 10 URINALYSIS REAGENT STRIPS Arj Medical, Inc. CDM Class I 2006-12-05
K062674 MISSION TRINITY B Diamond Diagnostics, Inc. JJY Class I 2006-12-01
K062581 OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM Olympus America, Inc. JLW Class II 2006-11-29
K062855 CALCIUM Abbott Laboratories CJY Class II 2006-11-22
K063212 CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2006-11-22
K062347 ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare, LLC NBW Class II 2006-11-22
K062467 AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 Axis-Shield Diagnostics, Ltd. CDD Class II 2006-11-22
K062593 CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET Compass Bioscience JJY Class I 2006-11-22
K063144 VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM Ortho-Clinical Diagnostics, Inc. JJE Class I 2006-11-13
K062434 ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 Agamatrix NBW Class II 2006-11-13
K061944 POLY-CHEM CREATININE Polymedco, Inc. JFY Class II 2006-11-03
K061830 STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ Nova Biomedical Corp. CIG Class II 2006-11-01
K061234 GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM Glucoplus, Inc. NBW Class II 2006-10-30
K062361 INNOVACON HCG UKTRA TEST DEVICE Innovacon, Inc. JHI Class II 2006-10-23
K062916 CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 Cliniqa Corporation JJY Class I 2006-10-23
K061549 AMNIOSTAT-FLM-PG Irvine Scientific Sales Co., Inc. JHG Class II 2006-10-18
K062668 AUDIT MICROCV IMMUNOASSAY LINEARITY SET Aalto Scientific, Ltd. JJY Class I 2006-10-16
K051968 ABL8X7 FLEX Radiometer Medical Aps CGL Class II 2006-10-16
K062808 LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT Catch Incorporated LPS Class II 2006-10-13
K062972 PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS Roche Diagnostics Corp. JJX Class I 2006-10-13
K062829 DIACHEX BLOOD GLUCOSE MONITORING SYSTEM Tyson Bioresearch, Inc. NBW Class II 2006-10-10
K061575 OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 Olympus America, Inc. CJY Class II 2006-10-05
K062035 DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL Dade Behring, Inc. JIX Class II 2006-10-04
K062751 MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER Quantimetrix Corp. JJT Class I 2006-10-03
K062180 ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP Horiba Abx JFJ Class II 2006-10-02
K062501 VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 Maine Standards Co. JJX Class I 2006-09-29
K061597 EPOC BLOOD ANALYSIS SYSTEM Epocal, Inc. JGS Class II 2006-09-27
K062334 DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 Dade Behring, Inc. JIX Class II 2006-09-22
K061979 MODIFICATION TO MYALLERGY TEST Immunetech Corporation JKA Class II 2006-09-22
K061528 SELFCHECK GLUCO Card Guard Scientific Survival , Ltd. CGA Class II 2006-09-22
K062204 ARCHITECT CORTISOL ASSAY Seradyn, Inc. JFT Class II 2006-09-22
K061598 HEMOSIL HOMOCYSTEINE AND CONTROLS Instrumentation Laboratory CO LPS Class II 2006-09-22
K062235 EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST Taidoc Technology Corporation NBW Class II 2006-09-19
K061992 EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 Eps Bio Technology Corp. CGA Class II 2006-09-19
K061190 ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 Beckman Coulter, Inc. CEW Class II 2006-09-15
K061974 GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT Instrumentation Laboratory CO CHL Class II 2006-09-15
K062092 PREVU POINT OF CARE SKIN STEROL TEST Premd, Inc. LBS Class I 2006-09-15
K062319 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 Roche Diagnostics Corp. JIX Class II 2006-09-13
K062239 GLUCOSE HK NEW FORMULATION TEST SYSTEM Roche Diagnostics Corp. CFR Class II 2006-09-11
K061795 DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR Dade Behring, Inc. NBC Class II 2006-09-11
K062058 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 Bayer Healthcare NBW Class II 2006-09-11
K061742 URYXXON RELAX URINE ANALYZER Macherey-Nagel GmbH & Co. KG JIL Class II 2006-09-06
K062316 DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE Dade Behring, Inc. JIF Class I 2006-09-06
K060765 HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 Hemocue AB LFR Class II 2006-09-06
K062034 DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) Dade Behring, Inc. JIX Class II 2006-09-06
K060578 CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) Scantibodies Laboratory, Inc. JKR Class II 2006-08-30
K061839 DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 Dade Behring, Inc. CIG Class II 2006-08-29
K061923 DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) Dade Behring, Inc. JIX Class II 2006-08-25
K062122 DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) Dade Behring, Inc. JIX Class II 2006-08-25
K061719 DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 Dade Behring, Inc. CIG Class II 2006-08-25
K060677 N LATEX CDT Dade Behring, Inc. NAO Class I 2006-08-25
K060854 ABX PENTRA 400: LIPOPROTEINS Horiba Abx JIT Class II 2006-08-24
K061838 DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 Dade Behring, Inc. JIX Class II 2006-08-21
K062128 THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS Dade Behring, Inc. JHS Class II 2006-08-21
K062236 DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE Dade Behring, Inc. MKW Class II 2006-08-21
K062195 MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2006-08-16
K062152 CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 Dade Behring, Inc. JIT Class II 2006-08-16
K060325 ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P Horiba Abx CIG Class II 2006-08-16
K061885 DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 Dade Behring, Inc. JIT Class II 2006-08-14
K061750 DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 Dade Behring, Inc. JIX Class II 2006-08-11
K061559 ACON URINALYSIS REAGENT STRIPS Acon Laboratories Co. CDM Class I 2006-08-11
K060620 ACCU-CHEK AVIVA TEST STRIPS Roche Diagnostics Corp. NBW Class II 2006-08-11
K061107 DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 Thermo Electron OY CEM Class II 2006-08-08
K060318 HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx CIT Class II 2006-08-08
K061793 DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR Dade Behring, Inc. JIY Class I 2006-08-07
K062055 DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH Dade Behring, Inc. JIX Class II 2006-08-07
K061730 OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 Osmetech, Inc. CEM Class II 2006-08-04
K061703 DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) Dade Behring, Inc. JIX Class II 2006-08-02
K061758 ACTIVE RENIN IRMA Diagnostic Systems Laboratories, Inc. CIB Class II 2006-07-28
K060793 ELEMENT BLOOD GLUCOSE TEST SYSTEM Home Diagnostics, Inc. NBW Class II 2006-07-25
K061588 VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc. LPS Class II 2006-07-21
K053597 I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) I-Stat Corporation NBC Class II 2006-07-21
K060205 GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx CJE Class II 2006-07-21
K060619 DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A Diazyme Laboratories KHS Class II 2006-07-21
K061056 RANDOX LIQUID PROTEIN CALIBRATOR Randox Laboratories, Ltd. JIX Class II 2006-07-20
K061818 DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) Dade Behring, Inc. JIT Class II 2006-07-18
K053236 DAVID PREGNANCY TEST (MIDSTREAM) Runbio Biotech Co.,Ltd LCX Class II 2006-07-18
K060467 PRODIGY BLOOD GLUCOSE TEST SYSTEM Diagnostic Devices, Inc. NBW Class II 2006-07-13
K061751 DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260 Dade Behring, Inc. JIT Class II 2006-07-13
K061702 DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) Dade Behring, Inc. JIT Class II 2006-07-10
K061181 ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 Taidoc Technology Corporation NBW Class II 2006-07-06
K061137 ADVIA IMS CPSA CONTROL Bayer Healthcare, LLC JJY Class I 2006-07-06
K061139 BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS Bayer Healthcare, LLC JIT Class II 2006-07-06
K053593 PRODIGY Diagnostic Devices, Inc. NBW Class II 2006-07-06
K061390 DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 Dade Behring, Inc. JIX Class II 2006-07-05
K061769 E.P.T. CERTAINTY 1-STEP PREGNANCY TEST Unipath , Ltd. LCX Class II 2006-07-03
K060480 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS Ortho-Clinical Diagnostics CGR Class II 2006-07-03
K061218 DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 Dade Behring, Inc. JIX Class II 2006-06-30
K061193 CREATININE Abbott Laboratories, Inc. CGX Class II 2006-06-23
K060510 DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT Drew Scientific , Ltd. JJX Class I 2006-06-19
K060825 MULTI-USE ELECTRONIC PREGNANCY TEST Mizuho USA, Inc. LCX Class II 2006-06-19
K052818 EZ SMART-168 GLUCOSE MONITORING SYSTEM Tyson Bioresearch, Inc. NBW Class II 2006-06-16
K061464 VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 Ortho-Clinical Diagnostics, Inc. JMO Class I 2006-06-15
K060364 VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE Teco Diagnostics JKA Class II 2006-06-15
K060875 ABBOTT AXSYM TROPONIN-I ADV Abbott Laboratories MMI Class II 2006-06-14
K061296 DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR Diazyme Laboratories LPS Class II 2006-06-13
K060280 ICHEM 100 URINE CHEMISTRY ANALYZER Iris International, Inc. JIL Class II 2006-06-13
K061328 THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) E-San Limited NBW Class II 2006-06-13

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