meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
35
Latest Decision
2011-02-04

Clearances · page 16 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K101392 NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D Astoria-Pacific, Inc. KQP Class II 2011-02-04
K101673 URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 Teco Diagnostics JIL Class II 2011-02-04
K103387 MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL ACON Laboratories, Inc. JJW Class I 2011-02-02
K103612 DIMENSION VISA ENZ 2 CAL Siemens Healthcare Diagnostics, Inc. JIX Class II 2011-01-25
K103271 MSC LIPID CONTROL Maine Standards Co. JJY Class I 2011-01-25
K103450 FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE Fujirebio Diagnostics,Inc. JJX Class I 2011-01-25
K101741 DIATRON PICTUS 400 Diatron Group CGA Class II 2011-01-25
K102814 ELECYSYS SHBG Roche Diagnostics CDZ Class I 2011-01-20
K102432 DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, Diazyme Laboratories MRG Class II 2011-01-14
K101216 AUDIT MICROCV PROTEIN LINEARITY SET Aalto Scientific, Ltd. JJY Class I 2011-01-14
K100829 EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 Medica Corp. JGS Class II 2011-01-14
K102959 PROLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. JGS Class II 2011-01-14
K102617 AUDIT MICROCV CARDIAC MARKERS LINEARITY SET Aalto Scientific, Ltd. JJY Class I 2011-01-10
K093280 OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 Opti Medical Systems, Inc. CHL Class II 2011-01-07
K103402 ELECSYS DHEA-S CALCHECK 5 Roche Diagnostics JJX Class I 2011-01-07
K101371 ON CALL PLUS DIABETES MONITORING SOFTWARE ACON Laboratories, Inc. NBW Class II 2011-01-07
K100715 AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 Aalto Scientific, Ltd. JJX Class I 2010-12-23
K103221 ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 Roche Diagnostics JIT Class II 2010-12-23
K101427 AUDIT MICROCV HS-CRP LINEARITY SET Aalto Scientific, Ltd. JJX Class I 2010-12-23
K102700 LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS Alere, San Diego, Dba Biosite INcorporated, Dba IN JJY Class I 2010-12-21
K100937 PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE I-Sens, Inc. NBW Class II 2010-12-21
K103360 DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL Siemens Corp. JIT Class II 2010-12-17
K102419 GSP NEONATAL IRT KIT (3306-001U) Wallac Oy, Subsidiary of Perkinelmer JNO Class I 2010-12-16
K100525 ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 Seppim S.A.S. CGA Class II 2010-12-15
K100060 EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 Vital Diagnostics (Manufacturing) Ptyltd KHS Class II 2010-12-15
K100777 ABL837 FLEX ANALYZER Radiometer Medical Aps CHL Class II 2010-12-10
K103099 PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH Roche Diagnostics JJX Class I 2010-12-06
K103340 SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM Harvest Technologies, Corp. JQC Class I 2010-12-06
K102638 DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS Diazyme Laboratories JIT Class II 2010-11-30
K102904 ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL Siemens Healthcare Diagnostics JJX Class I 2010-11-23
K103162 ELECSYS PTH CALCHECK 5 Roche Diagnostics JJX Class I 2010-11-18
K093758 BGM GALECTIN -3 Bg Medicine, Inc. OSX Class II 2010-11-17
K103041 VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR Greiner Bio-One North America, Inc. JKA Class II 2010-11-09
K102086 ELECSYS CA 125 II CALCHECK 5 Roche Diagnostics JJX Class I 2010-11-01
K102314 3M INTEGRATED CYCLER (110V) & (220V) Focus Diagnostics, Inc. OOI Class II 2010-10-29
K101921 VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT Ortho-Clinical Diagnostics CEW Class II 2010-10-22
K102441 NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN Nano-Ditech Corporation MMI Class II 2010-10-20
K102131 NANO-CHECK AMI CTNI CARDIAC MARKER TEST Nano-Ditech Corporation MMI Class II 2010-10-20
K101597 WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 Agamatrix NBW Class II 2010-10-18
K102269 ELECSYS IGE CALCHECK 5 Roche Diagnostics JJX Class I 2010-10-07
K101365 ELECSYS CA 19-9 CALCHECK 5 Roche Diagnostics Corp. JJX Class I 2010-10-05
K101809 FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 Fujirebio Diagnostics,Inc. JJY Class I 2010-10-05
K101856 ELECSYS CEA CALCHECK 5 Roche Diagnostics JJX Class I 2010-10-05
K100550 POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC Polymedco, Inc. LBS Class I 2010-09-28
K093137 K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL Kamiya Biomedical Co. NDY Class II 2010-09-28
K102260 FDI GLUCOSE CONTROL SOLUTIONS Fujirebio Diagnostics,Inc. JJX Class I 2010-09-24
K093883 AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- Seppim S.A.S. CIT Class II 2010-09-20
K100727 LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK Bio-Rad, Diagnostics Grp. JJY Class I 2010-09-14
K093960 ST AIA-PACK CYSTATIN C, MODEL 025217 Tosoh Bioscience, Inc. NDY Class II 2010-09-14
K102267 ELECSYS FERRITIN CALCHECK 5 Roche Diagnostics JJX Class I 2010-09-10
K101456 ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM Roche Diagnostics JIX Class II 2010-09-08
K100718 AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 Aalto Scientific, Ltd. JJY Class I 2010-09-03
K102016 PRECICONTROL CLINCHEM MULTI 1 AND 2 Roche Diagnostics JJY Class I 2010-09-01
K101226 AUDIT MICROCV RF/CRP LINEARITY SET Aalto Scientific, Ltd. JJY Class I 2010-08-31
K102044 ELECSYS DIGOXIN CALCHECK 5 Roche Diagnostics JJX Class I 2010-08-31
K100307 GELSCAN, MODEL 1206 Sebia CFE Class II 2010-08-31
K101633 NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH Nova Biomedical Corp. JJY Class I 2010-08-27
K102157 ELECSYS PRECICONTROL MULTIMARKER Roche Diagnostics JJY Class I 2010-08-27
K102175 RAPIDVUE HCG TEST Quidel Corporation JHI Class II 2010-08-25
K093916 NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U Perkinelmer, Inc. NQL Class II 2010-08-23
K101390 FASTPACK TSH IMMUNOASSAY Qualigen, Inc. JLW Class II 2010-08-13
K102037 AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS Apex BioTechnology Corp. CGA Class II 2010-08-13
K092875 ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER Taidoc Technology Corporation NBW Class II 2010-08-13
K092686 ABL90 FLEX SERIES Radiometer Medical Aps CEM Class II 2010-08-06
K092937 STA-HYBRID HEP CALIBRATOR Diagnostica Stago, Inc. JIT Class II 2010-08-02
K093724 FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION Taidoc Technology Corporation JJX Class I 2010-07-29
K100682 GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U Wallac OY JLX Class I 2010-07-23
K101434 AUDIT MICROCV PROCALCITONIN LINEARITY Aalto Scientific, Ltd. MJX Class I 2010-07-22
K093262 AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM Andon Medical Co., Ltd. NBW Class II 2010-07-13
K093910 IMPROVACUTER GEL & CLOT ACTIVATOR TUBE Guangzhou Improve Medical Instruments Co., Ltd. JKA Class II 2010-07-12
K101460 LOCI 8 CALIBRATOR, MODEL KC 646 Siemens Healthcare Diagnostics JIX Class II 2010-07-09
K100732 FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 Taidoc Technology Corporation NBW Class II 2010-07-09
K100405 FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation CGA Class II 2010-07-09
K093383 NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG bioMerieux, Inc. OOI Class II 2010-07-06
K101457 EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 Eps Bio Technology Corp. NBW Class II 2010-07-01
K101502 BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 Becton, Dickinson & CO JKA Class II 2010-06-29
K100322 TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 Taidoc Technology Corporation NBW Class II 2010-06-28
K091849 IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET Immunodiagnostic Systems, Inc. MRG Class II 2010-06-25
K093357 DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D Diamond Diagnostics, Inc. JIT Class II 2010-06-24
K093623 GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO Instrumentation Laboratory CO CIG Class II 2010-06-18
K092052 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 Bionime Corporation NBW Class II 2010-06-18
K092638 FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 Abbott Diabetes Care, Inc. NBW Class II 2010-06-15
K100101 GSP NEONATALGALT KIT, MODEL 3303-001U Perkinelmer, Inc. KQP Class II 2010-06-11
K101075 ELECSYS INSULIN CALCHECK 5 Roche Diagnostics Corp. JJX Class I 2010-06-11
K093297 EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE Epocal, Inc. KHP Class I 2010-06-09
K093819 ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) Arkray Factory USA, Inc. NBW Class II 2010-06-09
K100398 SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM Standard Diagnostics, Inc. NBW Class II 2010-06-09
K092705 ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 Abbott Molecular, Inc. OOI Class II 2010-05-28
K091168 GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 Infopia Co, Ltd. NBW Class II 2010-05-27
K100750 AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 Aalto Scientific, Ltd. JJX Class I 2010-05-21
K092602 FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System Abbott Diabetes Care, Inc. NBW Class II 2010-05-14
K100010 HDL CHOLESTEROL (HDLX) ASSAY Beckman Coulter, Inc. LBS Class I 2010-05-14
K100560 EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 Biotest Medical Corp. NBW Class II 2010-05-12
K100406 FORA V20 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation CGA Class II 2010-05-11
K100289 ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 Siemens Healthcare Diagnostics KHS Class II 2010-05-10
K100778 DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A Siemens Healthcare Diagnostics JIX Class II 2010-05-05
K100187 EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT Medica Corp. CGA Class II 2010-05-05
K094005 FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2010-05-05
K093128 ILLUMINA BEADXPRESS SYSTEM Illumina, Inc. NSU Class II 2010-04-28
K091472 URITEST 50 AND URITEST 500 URINE ANALYZER Arj Medical, Inc. KQO Class I 2010-04-27

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