meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
35
Latest Decision
2011-09-27

Clearances · page 15 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K103396 COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION I-Sens, Inc. NBW Class II 2011-09-27
K111516 NMR LIPOPROFILE (R) TEST AND NMR PROFILER Liposcience, Inc. LBS Class I 2011-09-27
K110435 EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM U. S. Diagnostics, Inc. NBW Class II 2011-09-21
K101299 ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics LFR Class II 2011-09-21
K110061 CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics JJX Class I 2011-09-21
K112356 GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE Bionostics, Inc. JJX Class I 2011-09-19
K100806 DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM Delbio Incorporation NBW Class II 2011-09-16
K111728 EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM Eps Bio Technology Corp. CGA Class II 2011-09-16
K102816 GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS Apex BioTechnology Corp. NBW Class II 2011-09-15
K111996 ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 Elitechgroup JJY Class I 2011-09-14
K112113 ELECSYS MYOGLOBIN CALCHECK 5 Roche Diagnostics JJX Class I 2011-09-14
K103615 ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD Alfa Wassermann Diagnostic Technologies, Inc. CDN Class II 2011-09-08
K110818 POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS Polymedco, Inc. CIX Class II 2011-09-08
K110637 ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM Cilag GmbH International LFR Class II 2011-09-07
K112272 EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM Eps Bio Technology Corp. LFR Class II 2011-09-07
K111650 IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... Immunodiagnostic Systems , Ltd. JJX Class I 2011-09-06
K101631 FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2011-09-02
K111143 POLY-CHEM 90 TOTAL BILIRUBIN Polymedco, Inc. CIG Class II 2011-09-01
K103747 ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS Elitechgroup Seppim S.A.S. LBS Class I 2011-08-31
K101204 MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION Apex BioTechnology Corp. CGA Class II 2011-08-31
K101635 TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2011-08-31
K101543 TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 Tyson Bioresearch, Inc. NBW Class II 2011-08-30
K112029 ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 Elitechgroup JIX Class II 2011-08-30
K110648 NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM Nova Biomedical Corporation CHL Class II 2011-08-29
K102678 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS Andon Medical Co., Ltd. NBW Class II 2011-08-26
K112104 ELECSYS N-MID OSTEOCALCIN CALCHECK 5 Roche Diagnostics JJX Class I 2011-08-25
K102706 CKMB UDR ASSAY SENTINEL CH. SpA JHS Class II 2011-08-19
K111952 ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 Beckman Coulter, Inc. JIT Class II 2011-08-19
K100602 NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS Nova Biomedical Corp. KHP Class I 2011-08-17
K110277 RAPIDPOINT 405 NEONATAL BILIRUBIN Siemens Healthcare Diagnostics MQM Class I 2011-08-15
K110137 ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN HORIBA ABX SAS JFY Class II 2011-08-10
K101307 BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 Andon Medical Co., Ltd. NBW Class II 2011-08-09
K102188 CYBOW READER, MODELS 300 & 720 DFI Co., Ltd. KQO Class I 2011-08-09
K111762 ST AIA-PACK DHEA-S CALIBRATOR SET Tosoh Bioscience, Inc. JIT Class II 2011-08-05
K102760 ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 Atlas Medical LCX Class II 2011-08-03
K110571 TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE Telcare, Inc. NBW Class II 2011-07-28
K103574 PREGNANCY ONE STEP RAPID TEST Lehnus & Associates Consulting LCX Class II 2011-07-28
K111552 ELECSYS T3 CALCHECK 5 Roche Diagnostics JJX Class I 2011-07-21
K111897 ABL90 Radiometer Medical Aps CHL Class II 2011-07-19
K093755 AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM Andon Medical Co., Ltd. NBW Class II 2011-07-15
K102643 SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT Astoria-Pacific, Inc. KQP Class II 2011-07-15
K111036 EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT Medica Corporation LBS Class I 2011-07-12
K111506 ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics JJY Class I 2011-07-08
K092688 FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation LFR Class II 2011-07-06
K110880 VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT Maine Standards Company, LLC JJY Class I 2011-07-05
K111029 FORA POCT MANAGMENT SYSTEM Taidoc Technology Corporation NBW Class II 2011-07-01
K110616 THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO Microgenics Corp. JJY Class I 2011-06-29
K111063 VITAL SERUM CONTROLS Vital Diagnostics (Manufacturing) Ptyltd JJY Class I 2011-06-28
K110035 INDIKO Thermofisher Scientific OY JJE Class I 2011-06-28
K101509 U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2011-06-27
K110830 ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH Elitechgroup CIX Class II 2011-06-21
K102345 EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 Eps Bio Technology Corp. NBW Class II 2011-06-21
K110889 IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) Ind Diagnostics, Inc. LCX Class II 2011-06-20
K103601 AUDIT MICROCV IMMUNOASSAY LINEARITY SET Aalto Scientific, Ltd. JJY Class I 2011-06-10
K110274 AUTODELFIA NEONATAL IRT KIT Wallac Oy, A Subsidiary of Perkinelmer, Inc. JNO Class I 2011-06-10
K111023 ABBOTT ARCHITECT LH CALIBRATORS Abbott Laboratories JIT Class II 2011-06-10
K110394 ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) Vital Diagnostics (Manufacturing) Ptyltd JIX Class II 2011-06-09
K111349 ELECSYS SHBG CALCHECK 5 Roche Diagnostics JJX Class I 2011-06-09
K103548 ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 Siemens Healthcare Diagnostics, Inc. JIT Class II 2011-06-02
K102049 CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2011-05-27
K110641 FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL Fujirebio Diagnostics,Inc. JJX Class I 2011-05-27
K110251 SYNCHRON MULTI CALIBRATOR Beckman Coulter, Inc. JIX Class II 2011-05-25
K101037 EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 Eps Bio Technology Corp. LFR Class II 2011-05-23
K101090 EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS Medica Corp. CJE Class II 2011-05-20
K110709 ARK CARE DIABETES MANAGMENT SYSTEM Arkray Factory USA, Inc. NBW Class II 2011-05-19
K102993 ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL Seppim S.A.S. CDT Class I 2011-05-19
K100130 PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 Mitsubishi Chemical Medience CO MMI Class II 2011-05-16
K110948 HEALTH CARE SYSTEM SOFTWARE Taidoc Technology Corporation NBW Class II 2011-05-13
K103744 DROPPER A1C DIABETES CONTROL Quantimetrix Corp. JJX Class I 2011-05-12
K110433 CLEARBLUE EASY PREGNANCY TEST SPD Development Company Limited LCX Class II 2011-05-12
K103716 ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET Roche Diagnostics CGN Class II 2011-05-12
K110613 ELECSYS PROLACTIN II CALCHECK 5 Roche Diagnostics JJX Class I 2011-05-12
K110413 POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS Beckman Coulter, Inc. CDD Class II 2011-05-11
K103364 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL Diamond Diagnostics, Inc. JJY Class I 2011-05-06
K102568 URIC ACID MODEL 3P39 Abbott Laboratories KNK Class I 2011-05-06
K100263 ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS Seppim S.A.S. CEO Class I 2011-05-06
K103112 AFFYMETRIX GENE PROFILING REAGENTS Affymetrix, Inc. OVA Class II 2011-05-04
K102481 AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP Apex BioTechnology Corp. NBW Class II 2011-04-28
K103683 IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) Siemens Healthcare Diagnostics JJX Class I 2011-04-28
K103842 UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 Beckman Coulter, Inc. CGA Class II 2011-04-27
K103484 GSP NEONATAL THYROXINE (T4) Wallac Oy, A Subsidiary of Perkinelmer, Inc. KLI Class II 2011-04-22
K110675 EASYRA UREA NITROGEN AND CREATININE REAGENTS Medica Corp. CDQ Class II 2011-04-21
K110436 FDI GLUCOSE CONTROL SOLUTION FOR AVIVA Fujirebio Diagnostics,Inc. JJX Class I 2011-04-20
K110169 DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H Siemens Healthcare Diagnostics JIT Class II 2011-04-07
K101088 EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT Medica Corp. CIX Class II 2011-04-04
K110416 ABL835 FLEX ANALYZER WITH PLEURAL PH Radiometer Medical Aps CHL Class II 2011-03-24
K102647 ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... Elitechgroup Vital Scientific BV JGS Class II 2011-03-24
K101852 CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT Iris International Inc., A Division of Iris Iris I KQO Class I 2011-03-23
K101947 IVD-GE02 Sphere Medical , Ltd. CGA Class II 2011-03-16
K110412 IDS-ISYS IFG-I CONTROL SET Immunodiagnostic Systems , Ltd. JJX Class I 2011-03-16
K101854 ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 Siemens Healthcare Diagnostics CFR Class II 2011-03-07
K103701 ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS Siemens Healthcare Diagnostics, Inc. JIX Class II 2011-02-18
K101388 FASTPACK TESTO IMMUNOASSAY Qualigen, Inc. CDZ Class I 2011-02-18
K100024 TECO DIAGNOSTICS UTI DETECTION STRIPS Teco Diagnostics JMT Class I 2011-02-17
K103836 ENZYME II CALIBRATOR Siemens Healthcare Diagnostics, Inc. JIT Class II 2011-02-16
K103171 ELECSYS ANTI-TPO CALSET Roche Diagnostics JIX Class II 2011-02-11
K093745 ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2011-02-11
K103553 LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION Bionostics, Inc. JJX Class I 2011-02-10
K103195 I-STAT 1 WIRELESS ANALYZER Abbott Point of Care, Inc. CGA Class II 2011-02-08
K103403 MULTICONSTITUENT CALIBRATOR Abbott Laboratories JIX Class II 2011-02-04

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