meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
43
Latest Decision
2007-07-10

Clearances · page 21 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K063357 MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES Greiner Bio-One North America, Inc. JKA Class II 2007-07-10
K071675 LIQUICHEK TUMOR MARKER CONTROL Bio-Rad Laboratories JJY Class I 2007-07-03
K062377 MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 Medapps, Inc. NBW Class II 2007-07-03
K070921 BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG Applied Dna Technologies, Inc. JHI Class II 2007-06-29
K070559 POLYMAP PWR-08-03 Polymap Wireless NBW Class II 2007-06-29
K071030 BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC Applied Dna Technologies, Inc. JHI Class II 2007-06-29
K071433 SMS GLUCOSE CONTROL, MODEL 2120059 Specialty Medical Supplies JJY Class I 2007-06-28
K063376 EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER Medica Corp. CHL Class II 2007-06-25
K070524 MICRODOT BLOOD GLUCOSE MONITORING SYSTEM Cambridge Sensors Limited NBW Class II 2007-06-22
K070383 ENZYMATIC CREATININE ASSAY (265 SERIES) Diagnostic Chemicals , Ltd. JFY Class II 2007-06-22
K070941 CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 Taidoc Technology Corporation NBW Class II 2007-06-21
K063605 ST AIA-PACK INTACT PTH ASSAY Tosoh Bioscience, Inc. CEW Class II 2007-06-21
K070666 GENESISCS COMPONENT CONCENTRATING SYSTEM Perfusion Partners & Assoc., Inc. JQC Class I 2007-06-20
K063232 ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 Biokit, S.A. CEW Class II 2007-06-19
K070255 NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 Nova Biomedical Corp. NBW Class II 2007-06-13
K062737 CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx CGS Class II 2007-06-12
K060434 ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL Horiba Abx CIX Class II 2007-06-05
K070835 OLYMPUS CK-MB REAGENT Olympus Life & Material Science Europa GmbH (Irish JHY Class II 2007-06-04
K071283 SYNCHRON SYSTEMS CREATININE REAGENT Beckman Coulter, Inc. CGX Class II 2007-06-01
K071280 SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS Beckman Coulter, Inc. CGX Class II 2007-06-01
K071277 SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS Beckman Coulter, Inc. CGX Class II 2007-06-01
K071216 VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 Ortho-Clinical Diagnostics, Inc. JFY Class II 2007-05-25
K070585 ACCU-CHEK PERFORMA SYSTEM Roche Diagnostics Corp. NBW Class II 2007-05-25
K063868 MASSTRAK IMMUNOSUPPRESSANTS KIT Waters Corporation MLM Class II 2007-05-25
K071215 VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 Ortho-Clinical Diagnostics, Inc. JFY Class II 2007-05-25
K070239 MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM Exir Pharmaceutical Co. NBW Class II 2007-05-25
K070971 MODIFICATION TO SENTINEL CLIN CHEM CAL Sentinel Ch. Srl JIX Class II 2007-05-23
K070064 AMYLASE EPS REAGENT Thermo Fisher Scientific JFJ Class II 2007-05-22
K062395 ACCU-CHEK SMART PIX Roche Diagnostics Corp. NBW Class II 2007-05-09
K070068 NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS Nova Biomedical Corp. CGL Class II 2007-05-07
K070593 TRACKRECORD DATA MANAGEMENT SOFTWARE Home Diagnostics, Inc. NBW Class II 2007-05-07
K062096 KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST Koreamedico Co. , Ltd. LCX Class II 2007-05-07
K070741 CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 Cliniqa Corporation JJY Class I 2007-05-04
K061257 DBEST HCG PANEL TEST KIT Ameritek USA, Inc. JHI Class II 2007-05-04
K070054 FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST Church & Dwight Co., Inc. LCX Class II 2007-05-04
K070552 DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) Dade Behring, Inc. JIT Class II 2007-04-30
K070251 CARBON DIOXIDE LIQUID STABLE REAGENT Pointe Scientific, Inc., KHS Class II 2007-04-30
K062538 EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM Diacare Corp. NBW Class II 2007-04-30
K070249 ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H Horiba Abx CIC Class II 2007-04-26
K070848 LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X Bio-Rad, Diagnostics Grp. JJW Class I 2007-04-25
K062105 DIAZYME CREATININE LIQUID REAGENTS ASSAY Diazyme Laboratories JFY Class II 2007-04-23
K070506 SMS MULTI GLUCOSE CONTROL, MODEL 2120049 Medical Specialties Supply Co., Inc. JJX Class I 2007-04-18
K070207 MULTI-ANALYTE CHEMISTRY CALIBRATOR Pointe Scientific, Inc., JIX Class II 2007-04-13
K070649 SMS GLUCOSE CONTROL, MODEL 2120061 Spectrum Medical Supply, Inc. JJX Class I 2007-04-12
K070504 AMMONIA/ALCOHOL CONTROL SET Pointe Scientific, Inc., JJY Class I 2007-04-11
K063701 TECO HOMOCYSTEINE ENZYMATIC ASSAY Teco Diagnostics LPS Class II 2007-04-11
K070850 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. NBW Class II 2007-04-10
K070641 ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 Taidoc Technology Corporation NBW Class II 2007-04-09
K063720 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS Ortho-Clinical Diagnostics DHA Class II 2007-04-09
K061846 COMBI SCAN100 Analyticon Biotechnologies AG JIL Class II 2007-04-06
K061812 COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 Analyticon Biotechnologies AG JIL Class II 2007-04-06
K062862 OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 Olympus America, Inc. KNK Class I 2007-04-06
K062957 FASTPACK TOTAL PSA METHOD VERIFICATION KIT Qualigen, Inc. JJX Class I 2007-04-02
K062120 CISBIO RENIN RIA TEST Cis Bio International CIB Class II 2007-03-30
K061377 APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS Pointe Scientific, Inc., MSJ Class I 2007-03-28
K061412 THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 Thermo Electron Corp. JFY Class II 2007-03-23
K063804 OLYMPUS TRIGLYCERIDE TEST SYSTEM Olympus America, Inc. CDT Class I 2007-03-23
K070391 ELECSYS PTH TEST SYSTEM Roche Diagnostics Corp. CEW Class II 2007-03-20
K063756 DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE Dade Behring, Inc. MMI Class II 2007-03-19
K070200 TDM CONTROL SET, MODEL CAT# 04521536 Roche Diagnostics Corp. JJY Class I 2007-03-19
K062521 OXALATE URINE CONTROLS (NORMAL AND ELEVATED) Thermo-Electron Corp. JIT Class II 2007-03-16
K070472 CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 Taidoc Technology Corporation NBW Class II 2007-03-15
K060452 ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH Neo-Genesis JLX Class I 2007-03-13
K070223 AUDIT MICROCV LIPIDS LINEARITY SET (LOW) Aalto Scientific, Ltd. JJY Class I 2007-03-13
K063647 CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH Thermo Electron OY NDY Class II 2007-03-12
K062026 VAP-NT CHOLESTEROL TEST Atherotech, Inc. CHH Class I 2007-03-06
K063390 URINE CHEMISTRY ANALYZER UR-50 Ind Diagnostic, Inc. JIL Class II 2007-03-01
K063754 DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 Dade Behring, Inc. DHA Class II 2007-02-23
K061775 WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR Wako Chemicals USA, Inc. JFY Class II 2007-02-23
K063608 DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH Dade Behring, Inc. MSJ Class I 2007-02-23
K070088 ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. NBW Class II 2007-02-16
K062567 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM Bionime Corporation NBW Class II 2007-02-16
K063026 OK METER BLOOD GLUCOSE MONITORING SYSTEM Ok Biotech Co., Ltd. NBW Class II 2007-02-09
K062799 GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. CGA Class II 2007-02-06
K063855 LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 Liberty Healthcare Group, Inc. JJX Class I 2007-02-01
K070144 INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. JIT Class II 2007-02-01
K070017 PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS Polymer Technology Systems, Inc. NBW Class II 2007-01-31
K062379 COBAS INTEGRA CERULOPLASMIN Roche Diagnostics Corp. JJY Class I 2007-01-31
K061419 TECO MICROALBUMIN 2-1 COMBO STRIPS Teco Diagnostics JIR Class I 2007-01-26
K061886 ACTIM PROM AND CONTROLS Medix Biochemica OAM Class I 2007-01-25
K063821 NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM Nova Biomedical Corp. CGA Class II 2007-01-24
K060818 ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 Biokit, S.A. CDZ Class I 2007-01-23
K063508 DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN Dade Behring, Inc. JIX Class II 2007-01-23
K062892 EUKARE Eumed Biotechnology Co., Ltd. CGA Class II 2007-01-22
K063351 DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH Dade Behring, Inc. NDY Class II 2007-01-22
K063208 MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 Diagnostic Chemicals , Ltd. JGJ Class I 2007-01-19
K062503 CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT Catachem, Inc. KWW Class II 2007-01-19
K063744 COBAS INTEGRA C 111 Rochdiag CIG Class II 2007-01-17
K062800 CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO Taidoc Technology Corporation NBW Class II 2007-01-12
K061431 EASYGLUCO, MODEL IGM-0002 G2 U. S. Diagnostics, Inc. CGA Class II 2007-01-12
K063409 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 Agamatrix NBW Class II 2007-01-12
K063276 CLINITEK ADVANTUS, MODEL 1420 Bayer Healthcare, LLC JIL Class II 2006-12-28
K063206 DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH Dade Behring, Inc. LPS Class II 2006-12-28
K062555 EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G Visgeneer, Inc. NBW Class II 2006-12-27
K061841 QUANTA LITE INTRINSIC FACTOR ELISA Inova Diagnostics, Inc. LIG Class II 2006-12-22
K063543 COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 Roche Diagnostics Corp. CIG Class II 2006-12-22
K063068 FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 Arkray USA, Inc. NBW Class II 2006-12-20
K062626 CORTISOL ELISA Ibl-Hamburg GmbH CGR Class II 2006-12-20
K062838 VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 Ortho-Clinical Diagnostics MMI Class II 2006-12-19
K061879 SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM Hemodiagnostica, LLC CFR Class II 2006-12-15

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