meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
42
Latest Decision
2012-12-21

Clearances · page 13 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K122142 GLOOKO LOGBOOK CHARTS Glooko, Inc. NBW Class II 2012-12-21
K122435 NOVA ONE BLOOD GLUCOSE MONITOR Nova Biomedical Corporation LFR Class II 2012-12-20
K121027 DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH Diamond Diagnostics, Inc. JIT Class II 2012-12-20
K123010 ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. NBW Class II 2012-12-14
K120866 DA01 BLOOD GLUCOSE MONITORING SYSTEM Delbio Incorporation NBW Class II 2012-12-11
K120813 BLOOD GLUCOSE MONITORING SYSTEM Andon Medical Co., Ltd. NBW Class II 2012-12-07
K122242 ELECSYS CA 15-3 II CALCHECK 5 Roche Diagnostics JJX Class I 2012-12-05
K121994 DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR Siemens Healthcare Diagnostics, Inc. CDD Class II 2012-11-30
K103542 GENSTRIP TEST STRIP MODEL 100-201 Shasta Technologies, LLC NBW Class II 2012-11-30
K122420 DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA Diazyme Laboratories MRG Class II 2012-11-28
K123379 ABBOTT ARCHITECT FREE T4 Abbott Laboratories CEC Class II 2012-11-27
K122110 ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. CGA Class II 2012-11-21
K120326 AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE Radiometer Medical Aps JHX Class II 2012-11-21
K121603 RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 Randox Laboratories, Ltd. JJY Class I 2012-11-20
K123198 LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA Bio-Rad Laboratories JJY Class I 2012-11-20
K122729 ABL90 FLEX Radiometer Medical Aps CHL Class II 2012-11-16
K113314 PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM Hmd Biomedical, Inc. LFR Class II 2012-11-09
K122642 ABL90 FLEX Radiometer Medical Aps CHL Class II 2012-10-26
K120765 VITROS CHEMISTRY PRODUCTS ECO2 SLIDES Ortho-Clinical Diagnostics, Inc. KHS Class II 2012-10-24
K122838 LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK Bio-Rad Laboratories JJY Class I 2012-10-17
K122398 RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS Siemens Healthcare Diagnostics, Inc. JIX Class II 2012-10-12
K121679 ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics NBW Class II 2012-10-11
K113726 EPOC CHLORIDE TEST AND EPOC CREATININE TEST Epocal, Inc. CGL Class II 2012-10-05
K122757 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT Alfa Wassermann Diagnostic Technologies, Inc. CHH Class I 2012-10-05
K122858 ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II Elitechgroup JFJ Class II 2012-10-03
K112449 QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST Tianjin New Bay Bioresearch Co., Ltd. LCX Class II 2012-09-24
K113720 RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 Randox Laboratories, Ltd. JJY Class I 2012-09-20
K121224 GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation LFR Class II 2012-09-19
K120009 TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) Abbott Laboratories CDZ Class I 2012-09-11
K113731 ESENSOR RESPIRATORY VIRAL PANEL Clinical Micro Sensors, Inc. JJH Class I 2012-09-10
K120609 VITROS CHEMISTRY PRODUCTS DHDL SLIDES Ortho-Clinical Diagnostics, Inc. LBS Class I 2012-09-07
K121654 AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION I-Sens, Inc. CGA Class II 2012-09-05
K120064 TEST, BLOOD GLUCOSE SYSTEM Hmd Biomedical, Inc. NBW Class II 2012-09-05
K122291 THERMO SCIENTIFIC MAS OMNI-CARDIO Microgenics Corporation JJY Class I 2012-08-31
K121012 FLEXLAB 3.6, ACCELERATOR A3600 Inpeco S.P.A. CEM Class II 2012-08-31
K121040 SMARTLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. CEM Class II 2012-08-30
K113830 VANTERA CLINICAL ANALYZER Liposcience CDT Class I 2012-08-30
K122323 DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI Siemens Healthcare Diagnostics CJO Class II 2012-08-28
K122302 ACE MAGNESIUM REGENT Alfa Wassermann Diagnostics Technologies, LLC JGJ Class I 2012-08-27
K121895 ELECSYS HSV-2 IGG IMMUNOASSAY Roche Diagnostics JJX Class I 2012-08-24
K120626 EON CALCIUM REGENT Vital Diagnostics (Manufacturing) Ptyltd CJY Class II 2012-08-22
K122083 ELITECH CLINICAL SYSTEMS CK NAC SL Elitechgroup JHW Class II 2012-08-22
K121140 PROLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. JGS Class II 2012-08-22
K120921 CLEVER CHOICE Simple Diagnostics, Inc. CGA Class II 2012-08-21
K112916 TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM Tyson Bioresearch, Inc. NBW Class II 2012-08-21
K122126 DIRECT LDL/HDL CHOLESTEROL CALIBRATOR Randox Laboratories Limited JIS Class II 2012-08-14
K113389 ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT Alfa Wassermann Diagnostic Technologies, Inc. CDN Class II 2012-08-10
K122141 IDS-ISYS IGF-I CALIBRATION VERIFIERS Immunodiagnostic Systems , Ltd. JJX Class I 2012-08-07
K113077 BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation NBW Class II 2012-08-03
K120423 BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 Bionime Corporation NBW Class II 2012-08-03
K121053 DIAZYME HOMOCYSTEINE POC TEST KIT Diazyme Laboratories LPS Class II 2012-07-31
K113307 GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM Hmd Biomedical, Inc. LFR Class II 2012-07-27
K120202 EON CHOLESTEROL REAGENT Vital Diagnostics Pty., Ltd. CHH Class I 2012-07-27
K121190 CONTOUR NEXT BLOOD GLUCOSE METER Bayer Healthcare, LLC LFR Class II 2012-07-26
K111260 A/C ENZYMATIC VITAMIN B6 ASSAY Anticancer, Inc. CDD Class II 2012-07-26
K121759 CONE-TROL LIQUID CHEMISTRY CONTROLS Cone Bioproducts JJY Class I 2012-07-24
K113546 ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 Roche Diagnostics MRG Class II 2012-07-24
K121907 DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR Siemens Healthcare Diagnostics CJO Class II 2012-07-23
K113382 ACE ALT REAGENT Alfa Wassermann CKA Class I 2012-07-19
K112101 FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS Polymed Therapeutics, Inc. JHI Class II 2012-07-17
K113374 ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT Alfa Wassermann Diagnostic Technologies, Inc. CIX Class II 2012-07-13
K113192 HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM Infopia Co, Ltd. NBW Class II 2012-07-13
K113436 ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT Alfa Wassermann CJE Class II 2012-07-12
K121794 LIQUICHEK URINE CHEMISTRY CONTROL Bio-Rad, Diagnostics Grp. JJY Class I 2012-07-11
K121746 RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) Randox Laboratories, Ltd. JJX Class I 2012-07-11
K121133 CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM I-Sens, Inc. NBW Class II 2012-07-10
K120649 AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. NBW Class II 2012-07-06
K113262 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT Alfa Wassermann Diagnostic Technologies, Inc. CHH Class I 2012-07-03
K113435 ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT Alfa Wassermann KHS Class II 2012-07-02
K121087 CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare NBW Class II 2012-06-28
K121468 EUROTROL GAS-ISE METABOLITES Eurotrol B.V. JJY Class I 2012-06-22
K120247 EASYDEX Vineland Syrup, Inc. MRV Class II 2012-06-21
K121534 CONE-TROL HEMOGLOBIN A1C CONTROL SET Cone Bioproducts JJX Class I 2012-06-20
K121588 RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 Randox Laboratories, Ltd. JJX Class I 2012-06-20
K112742 AUDIT MICROLQ SPINAL FLUID CONTROL Aalto Scientific, Ltd. JJY Class I 2012-06-15
K121533 ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET Tosoh Bioscience, Inc. LPS Class II 2012-06-15
K113793 HOMOCYSTEINE TEST Roche LPS Class II 2012-06-05
K120759 CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION I-Sens, Inc. CGA Class II 2012-06-05
K113438 ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT Alfa Wassermann Diagnostic Technologies, Inc. JMO Class I 2012-06-01
K110074 HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM Health & Life Co., Ltd. NBW Class II 2012-05-25
K120042 TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM Taidoc Technology Corporation LFR Class II 2012-05-22
K121237 BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE Cliniqa Corporation JJX Class I 2012-05-18
K121207 EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM Eps Bio Technology Corp. LFR Class II 2012-05-18
K121314 ARCHITECT B12 Abbott Laboratories CDD Class II 2012-05-17
K113253 ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT Alfa Wassermann Diagnostic Technologies, Inc. JJE Class I 2012-05-17
K120681 ADVIA CHEMISTRY GLUH_3 REAGENTS Siemens Healthcare Diagnostics, Inc. CFR Class II 2012-05-15
K111188 COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B Roche Diagnostics CHL Class II 2012-05-14
K120183 ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM Broadmaster Biotech Corperation NBW Class II 2012-05-11
K120369 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) Hitachi Chemical Diagnostics, Inc. CFR Class II 2012-05-10
K121279 ELECSYS LH CALCHECK 5 Roche Diagnostics JJX Class I 2012-05-10
K113177 COMPLETE D 25-OH VITAMIN D CONTROL Quantimetrix Corp. JJX Class I 2012-05-10
K121084 LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L Siemens Healthcare Diagnostics, Inc. JJX Class I 2012-05-09
K113521 CALCIUM GEN. 2 Roche Diagnostics CHW Class II 2012-05-08
K102841 PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY Pantex, Div. Bio-Analysis, Inc. NHG Class II 2012-05-08
K113670 ELEMENT BLOOD GLUCOSE MONITORING SYSTEM Infopia Co, Ltd. CGA Class II 2012-05-08
K112790 AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON Axis-Shield Diagnostics, Ltd. LPS Class II 2012-05-07
K112995 GEM PREMIER 4000 Instrumentation Laboratory CO CEM Class II 2012-05-03
K120351 CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA I-Sens, Inc. NBW Class II 2012-05-03
K113216 RAPIDPOINT 500 BLOOD GAS ANALYER Siemens Healthcare Diagnostics KHP Class I 2012-05-03
K110530 ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL HORIBA ABX SAS CGX Class II 2012-04-30

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