meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
45
Latest Decision
2013-07-03

Clearances · page 12 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K123171 ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT HORIBA ABX SAS CJY Class II 2013-07-03
K123983 FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS Qualigen, Inc. MRG Class II 2013-07-03
K123559 SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM Biotest Medical Corp. NBW Class II 2013-06-28
K130094 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM Abbott Diabetes Care NBW Class II 2013-06-27
K131556 DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET Diazyme Laboratories JIT Class II 2013-06-26
K130295 LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. Infopia Co, Ltd. NBW Class II 2013-06-21
K121101 SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT Astoria-Pacific, Inc. JIA Class I 2013-06-20
K130337 RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 Randox Laboratories Limited JJY Class I 2013-06-19
K123007 VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM Mico Biomed Co., Ltd. NBW Class II 2013-06-19
K123253 IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D Immunodiagnostic Systems , Ltd. MRG Class II 2013-06-18
K123016 VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS Mico Biomed Co., Ltd. NBW Class II 2013-06-18
K123087 TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM Tyson Bioresearch, Inc. NBW Class II 2013-06-18
K121214 ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM Beckman Coulter, Inc. MMI Class II 2013-06-14
K123127 VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 Maine Standards Co. JJX Class I 2013-06-14
K131051 HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) Hitachi Chemical Diagnostics, Inc. JGQ Class II 2013-06-07
K120945 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST Hitachi Chemical Diagnostics, Inc. CKA Class I 2013-06-07
K131217 S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN Hitachi Chemical Diagnostics, Inc. CIG Class II 2013-06-07
K130332 VITROS CHEMISTRY PRODUCTS TRIG SLIDES Ortho-Clinical Diagnostics, Inc. CDT Class I 2013-05-31
K131136 GLUCOSE METER-CHECK SOLUTION FOR TAIDOC Bionostics, Inc. JJX Class I 2013-05-31
K123844 CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST Chemtron Biotech, Inc. JHI Class II 2013-05-30
DEN130002 TINA-QUANT HBA1C GEN. 2 TEST SYSTEM Roche Diagnostics PDJ Class II 2013-05-23
K123726 COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 Roche Diagnostics JGS Class II 2013-05-21
K123322 ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT Alfa Wassermann Diagnostics Technologies, LLC CDN Class II 2013-05-21
K124040 FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2013-05-16
K123586 EASYRA CREATININE REAGENT Medica Corporation CGX Class II 2013-05-15
K120615 ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen CGA Class II 2013-05-15
K123930 VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. LPS Class II 2013-05-15
K123748 ABL90 FLEX Radiometer Medical Aps CHL Class II 2013-05-07
K130963 LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK Bio-Rad Laboratories, Inc. JJY Class I 2013-05-06
K130870 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) Hitachi Chemical Diagnostics, Inc. CIC Class II 2013-05-02
K122525 SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM Biotest Medical Corp. NBW Class II 2013-05-02
K123953 ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT Alfa Wassermann Diagnostic Technologies, Inc. KHS Class II 2013-05-02
K130762 AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET Aalto Scientific, Ltd. JJY Class I 2013-04-29
K130764 AUDIT MICROCV VITAMIN D LINEARITY SET Aalto Scientific, Ltd. JJX Class I 2013-04-26
K130886 GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION Glooko, Inc. NBW Class II 2013-04-25
K120989 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM Nipro Diagnostics, Inc. NBW Class II 2013-04-24
K123018 ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE Alfa Wassermann Diagnostic Technologies, Inc. CFR Class II 2013-04-23
K122539 MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM Siemens Healthcare Diagnostics CHL Class II 2013-04-19
K124009 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C Diamond Diagnostics, Inc. JJY Class I 2013-04-17
K130535 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION Agamatrix, Inc. NBW Class II 2013-04-17
K123935 IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM Andon Medical Co., Ltd. NBW Class II 2013-04-12
K130761 LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK Bio-Rad Laboratories JJY Class I 2013-04-12
K123703 HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) Healgen Scientific,, LLC LCX Class II 2013-04-10
K130321 LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS Diasorin CJM Class II 2013-04-09
K123089 FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 Abbott Laboratories NBW Class II 2013-04-05
K130698 DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) Siemens Healthcare Diagnostics JIT Class II 2013-04-05
K130469 LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 DiaSorin, Inc. JLW Class II 2013-04-05
K122307 DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM Biocare Corporation NBW Class II 2013-04-05
K122688 NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR Nova Biomedical Corporation LFR Class II 2013-04-04
K121951 LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 DiaSorin, Inc. CEC Class II 2013-04-04
K130765 ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II Elitechgroup JIX Class II 2013-04-04
K121823 CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC Wescor, Inc. JFS Class II 2013-03-27
K130415 HIGH METABOLITE QUALICHECK Radiometer Medical Aps JJS Class I 2013-03-26
K121946 AXIS-SHIELD ACVTIVE-B12 Axis-Shield Diagnostics, Ltd. CDD Class II 2013-03-22
K130141 S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) Hitachi Chemical Diagnostics, Inc. CJE Class II 2013-03-22
K130276 DIMENSION EXL WITH LM SYSTEM Siemens Healthcare Diagnostics, Inc. JJE Class I 2013-03-22
K121981 ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY Siemens Healthcare Diagnostics CEW Class II 2013-03-21
K130157 AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET Aalto Scientific, Ltd. JJX Class I 2013-03-19
K130236 RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 Radiometer Medical Aps JJS Class I 2013-03-15
K130138 SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM Roche Diagnostics Corp. NBW Class II 2013-03-15
K122907 FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER Polymed Therapeutics, Inc. LCX Class II 2013-03-14
K122534 IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. JJX Class I 2013-03-14
K121864 PERKINELMER 226 SAMPLE COLLECTION DEVICES Perkinelmer, Inc. PJC Class II 2013-03-12
K130113 PICCOLO LACTATE TEST SYSTEM Abaxis, Inc. KHP Class I 2013-03-11
K113636 BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) Philosys Co., Ltd. CGA Class II 2013-03-08
K123725 FASTPACK CONTROL KIT Qualigen, Inc. JJY Class I 2013-03-08
K123955 QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT Life Technologies Corporation OOI Class II 2013-03-08
K123677 DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) Siemens Healthcare Diagnostics JIF Class I 2013-03-07
K123136 GENESIS HEALTH RECORD SYSTEM, (GHRS) Genesis Health Technologies NBW Class II 2013-03-07
K123802 EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT Medica Corp. CIG Class II 2013-03-01
K130162 LIQUID ASSAYED MULTIQUAL PREMIUM Bio-Rad Laboratories JJY Class I 2013-03-01
K123965 COBAS INTEGRA BILIRUBIN DIRECT GEN.2 Roche Diagnostics CIG Class II 2013-02-28
K130200 PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM Abaxis, Inc. CHH Class I 2013-02-15
K122177 ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL Elitechgroup JIT Class II 2013-02-15
K123321 DIMENSION CHEMISTRY III CALIBRATORY Siemens Healthcare Diagnostics JIX Class II 2013-02-15
K121608 VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS Ortho-Clinical Diagnostics, Inc. MRG Class II 2013-02-15
K123320 DIMENSION AMMONIA FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics JIF Class I 2013-02-15
K123851 GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK Bionostics, Inc. JJX Class I 2013-02-14
K121433 GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS Hmd Biomedical, Inc. LFR Class II 2013-02-14
K113614 ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics NBW Class II 2013-02-12
K102751 LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM Ceragem Medisys, Inc. NBW Class II 2013-02-11
K123131 ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI Tosoh Bioscience, Inc. MRG Class II 2013-02-08
K120708 ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM Cilag GmbH International NBW Class II 2013-02-07
K120558 ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION Lifescan, Inc. NBW Class II 2013-02-07
K123050 EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) Nantong Biotechnology Co., Ltd. LCX Class II 2013-02-05
K121456 AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL Arkray, Inc. KQO Class I 2013-02-01
K121985 ARCHITECT TOTAL BILIRUBIN Abbott Laboratories CIG Class II 2013-02-01
K123775 LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK Bio-Rad Laboratories JJY Class I 2013-01-31
K123008 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN Bionime Corporation NBW Class II 2013-01-25
K123966 GLUCOSE METER-CHECK SOLUTION FOR BAYER Bionostics, Inc. JJX Class I 2013-01-25
K122793 LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET DiaSorin, Inc. CDZ Class I 2013-01-25
K123612 FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA Fujirebio Diagnostics,Inc. JJX Class I 2013-01-17
K123372 ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR Abbott Laboratories JIX Class II 2013-01-14
K121706 FORA V10 BLOOD GLUCOSE MONITORING SYSTEM Foracare, Inc. CGA Class II 2013-01-14
K122687 BLOOD CULTURE HOLDER Greiner Bio-One North America, Inc. JKA Class II 2013-01-10
K123798 LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK Bio-Rad Laboratories JJX Class I 2013-01-09
K121399 LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P Luminex Corp. NSU Class II 2013-01-09
K121944 LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT DiaSorin, Inc. CIB Class II 2013-01-01
K123663 LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK Bio-Rad Laboratories JJY Class I 2012-12-27
K120490 QUICK SAMPLER HOLDER Nipro Medical Corporation JKA Class II 2012-12-27

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