meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
41
Latest Decision
2009-08-18

Clearances · page 18 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K091481 EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM Eps Bio Technology Corp. NBW Class II 2009-08-18
K081360 PATHFAST CK-MB-II, PATHFAST MYO-II Mitsubishi Kagaku Iatron JHX Class II 2009-08-17
K091455 DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL Diazyme Laboratories MZV Class II 2009-08-14
K091742 SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 Beckman Coulter, Inc. JFY Class II 2009-08-14
K091123 ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS Siemens Healthcare Diagnostics JJX Class I 2009-08-14
K090332 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 Arkray Factory USA, Inc. NBW Class II 2009-08-14
K091460 ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 American Biological Technologies, Inc. JJX Class I 2009-08-06
K091333 S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 Alfa Wassermann, Inc. MRR Class I 2009-08-03
K091229 GLUCOMANAGER DATA MANAGEMENT SOFTWARE Eps Bio Technology Corp. NBW Class II 2009-07-31
K083222 AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 Axis-Shield Diagnostics, Ltd. LPS Class II 2009-07-31
K090734 EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES Medica Corp. MRR Class I 2009-07-17
K091296 POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 Polymap Wireless NBW Class II 2009-07-17
K090389 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM Bestgen Biotech Corp. NBW Class II 2009-07-14
K090188 U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 Taidoc Technology Corporation NBW Class II 2009-07-13
K091153 SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 Beckman Coulter, Inc. KHS Class II 2009-07-13
K083130 NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 Perkinelmer, Inc. NQL Class II 2009-07-09
K090541 ELECSYS PRECICONTROL UNIVERSAL Roche Diagnostics JJY Class I 2009-07-02
K091225 VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET Maine Standards Co. JJY Class I 2009-06-25
K090109 BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD Epocal, Inc. CGA Class II 2009-06-24
K090404 FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 Taidoc Technology Corporation NBW Class II 2009-06-23
K082340 ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS Roche Diagnostics Corp. CGN Class II 2009-06-19
K081150 RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST Turklab Medical Devices, Inc. LCX Class II 2009-06-16
K083716 FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) Church & Dwight Co., Inc. LCX Class II 2009-06-08
K090283 CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 Genchem, Inc. JIX Class II 2009-06-05
K090629 EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS Tyson Bioresearch, Inc. NBW Class II 2009-06-04
K090737 HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI Bio-Rad Laboratories, Inc. JKA Class II 2009-06-03
K090943 ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 American Biological Technologies, Inc. JJX Class I 2009-05-27
K090588 POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 Beckman Coulter, Inc. CDD Class II 2009-05-27
K090330 DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 Siemens Healthcare Diagnostics, Inc. JFY Class II 2009-05-22
K083184 TEARLAB OSMOLARITY SYSTEM Ocusense, Inc. OND Class I 2009-05-14
K090187 FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 Taidoc Technology Corporation NBW Class II 2009-05-12
K083844 ADVIA CENTAUR TSH3-ULTRA METHOD Siemens Healthcare Diagnostics JLW Class II 2009-05-08
K090311 ELECSYS RUBELLA IGG CALCHECK Roche Diagnostics JJX Class I 2009-05-05
K083628 GLUCODR AUTO SYSTEM All Medicus Co., Ltd. NBW Class II 2009-05-01
K090185 CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2009-04-24
K083554 CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 Cliniqa Corporation JJY Class I 2009-04-21
K072500 ONE STEP HCG URINE/SERUM TEST Guangzhou Wondfo Biotech Co., Ltd. DHA Class II 2009-04-21
K090475 VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 Maine Standards Co. JJY Class I 2009-04-16
K083223 RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 Abbott Diabetes Care, Inc. LFR Class II 2009-04-16
K081922 AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY JLX Class I 2009-04-16
K090854 ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 American Biological Technologies, Inc. JJX Class I 2009-04-16
K090043 AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 Apex BioTechnology Corp. CGA Class II 2009-04-09
K090057 ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories Co. NBW Class II 2009-04-08
K083809 CREATININE Abbott Laboratories CGX Class II 2009-04-07
K083386 ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) Siemens Healthcare Diagnostics CJY Class II 2009-04-02
K090495 TRUEBALANCE BLOOD GLUCOSE SYSTEM Home Diagnostics, Inc. NBW Class II 2009-03-27
K090536 FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247 Taidoc Technology Corporation NBW Class II 2009-03-26
K062187 BETACHEK GLUCOSE TEST National Diagnostic Products NBW Class II 2009-03-24
K083891 VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 Maine Standards Co. JJY Class I 2009-03-23
K080404 EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR Medica Corp. JIX Class II 2009-03-13
K083263 SYMCARE DIABETES MANAGEMENT PROGRAM Symcare Personalized Health Solutions, Inc. NBW Class II 2009-03-13
K083570 U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation CGA Class II 2009-03-11
K083906 ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 Siemens Healthcare Diagnostics NDY Class II 2009-03-11
K083339 DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) Siemens Healthcare Diagnostics, Inc. CIC Class II 2009-03-09
K083465 DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics CGS Class II 2009-02-27
K082328 GLUCODR PLUS SYSTEM, MODEL AGM-3000 All Medicus Co., Ltd. NBW Class II 2009-02-27
K083680 VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 Ortho-Clinical Diagnostics, Inc. CEM Class II 2009-02-27
K083462 DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 Siemens Healthcare Diagnostics JIT Class II 2009-02-27
K082638 ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL Siemens Healthcare Diagnostics, Inc. KLI Class II 2009-02-26
K080874 EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT Medica Corp. CIX Class II 2009-02-20
K080853 DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM Genexel-Sein, Inc. NBW Class II 2009-02-20
K082201 G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A U. S. Diagnostics, Inc. NBW Class II 2009-02-20
K083579 DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 Siemens Healthcare Diagnostics JIX Class II 2009-02-20
K080636 DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 Hubdic Co., Ltd. CGA Class II 2009-02-13
K083655 ELECSYS TOXO IGG CALCHECK Roche Diagnostics JJX Class I 2009-02-12
K083468 CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) I-Sens, Inc. NBW Class II 2009-02-10
K082462 GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ Diamond Diagnostics, Inc. JGS Class II 2009-02-06
K083265 JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 Agamatrix, Inc. NBW Class II 2009-02-03
K083373 IMMULITE 2000 FREE T4 Siemens Healthcare Diagnostics, Inc. CEC Class II 2009-02-02
K082482 FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 Taidoc Technology Corporation CGA Class II 2009-01-30
K081796 EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM Eps Bio Technology Corp. NBW Class II 2009-01-23
K081193 COBAS INTEGRA 400/800 BILIRUBIN TOTAL Roche Diagnostics CIG Class II 2009-01-16
K081908 CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 Cliniqa Corporation JJW Class I 2009-01-16
K082521 EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM Card Guard Scientific Survival , Ltd. NBW Class II 2009-01-16
K083099 EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 Eps Bio Technology Corp. NBW Class II 2009-01-16
K083430 REAL-TIME PCR INTERNAL CONTROL 2B SET Nanogen, Inc. OLD Class I 2009-01-15
K083664 FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 Taidoc Technology Corporation CGA Class II 2009-01-09
K081767 AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 Amnisure International, LLC NQM Class I 2009-01-09
K081703 MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS Entra Health Systems, Ltd. NBW Class II 2009-01-08
K082020 ENVISION BLOOD GLUCOSE TEST SYSTEM Infopia Co, Ltd. NBW Class II 2008-12-24
K083549 ABT GLUCOSE CONTROL SOLUTION American Biological Technologies, Inc. JJX Class I 2008-12-22
K083173 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM Ortho-Clinical Diagnostics JLW Class II 2008-12-22
K081715 FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM Taidoc Technology Corporation NBW Class II 2008-12-17
K082210 TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 Genzyme Diagnostics P.E.I., Inc. CIG Class II 2008-12-16
K081929 VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR Greiner Bio-One North America, Inc. JKA Class II 2008-12-16
K080810 EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT Medica Corp. CIG Class II 2008-12-10
K080485 ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS Diasys Diagnostics Systems GmbH CIT Class II 2008-12-04
K082169 PRO GLUCOSE TEST STRIP Taidoc Technology Corporation NBW Class II 2008-12-04
K081975 RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) Abbott Diabetes Care, Inc. NBW Class II 2008-11-26
K082714 AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 Aalto Scientific, Ltd. JJY Class I 2008-11-19
K080823 EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT Medica Corp. JFJ Class II 2008-11-17
K080623 CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA Jas Diagnostics, Inc. CHH Class I 2008-11-17
K082763 DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B Diazyme Laboratories MZU Class II 2008-11-12
K080294 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT Astoria-Pacific, Inc. NAK Class II 2008-11-04
K082717 AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 Aalto Scientific, Ltd. JJY Class I 2008-10-30
K081543 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM Ortho-Clinical Diagnostics, Inc. JLW Class II 2008-10-23
K082513 ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2008-10-22
K082417 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 Arkray Factory USA, Inc. CGA Class II 2008-10-21
K080923 CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB I-Sens, Inc. NBW Class II 2008-10-17
K080851 A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY Anticancer, Inc. LPS Class II 2008-10-10

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