meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
52
Latest Decision
2005-12-16

Clearances · page 24 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K052007 ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) Horiba Abx CFR Class II 2005-12-16
K053196 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) Inverness Medical Innovations, Inc. NJV Class II 2005-12-16
K051433 I-STAT CREATINE KINASE MB (CK-MB) I-Stat Corporation MYT Class II 2005-12-15
K052724 TECO ISE REAGENT SET FOR CX SYSTEM Teco Diagnostics JGS Class II 2005-12-14
K053165 ISE INDIRECT NA, K, CL FOR GEN.2 Roche Diagnostics Corp. JGS Class II 2005-12-14
K052503 TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM Bayer Healthcare, LLC MMI Class II 2005-12-14
K052208 GLUCOSE PILOT Tianjin New Bay Bioresearch Co., Ltd. NBW Class II 2005-12-09
K053157 AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A Dade Behring, Inc. LBS Class I 2005-12-09
K051714 TOTAL BILE ACIDS ASSAY, MODEL DZ042A Diazyme Laboratories KWW Class II 2005-12-07
K052343 E-SAN BLUETOOTH CRADLE E-San Limited NBW Class II 2005-12-07
K051733 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL Drg Intl., Inc. NHG Class II 2005-12-07
K052108 SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 Sein Electronics Co., Ltd. NBW Class II 2005-12-07
K051382 ELECSYS PROBNP IMMUNOASSAY Roche Diagnostics Corp. NBC Class II 2005-12-05
K052980 LIBERTY GLUCOSE CONTROL, MODEL 2120031 Liberty Healthcare Group, Inc. JJX Class I 2005-11-30
K052662 ONE STEP FSH MENOPAUSAL TEST Ind Diagnostic, Inc. CGJ Class I 2005-11-30
K051925 CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN Access Bio Incorporate MMI Class II 2005-11-29
K053059 ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK Roche Diagnostics JJX Class I 2005-11-28
K051114 SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY Sentinel Ch. Srl JIF Class I 2005-11-25
K051963 BE-CERTAIN PREGNANCY TEST Natureplex, LLC LCX Class II 2005-11-23
K051034 URYXXON 200 URINE ANALYZER Macherey-Nagel GmbH & Co. KG JIL Class II 2005-11-22
K052679 CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E Cliniqa Corporation JJX Class I 2005-11-18
K051111 SENTINEL UIBC LIQUID Sentinel Ch. Srl JQF Class I 2005-11-17
K051757 CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 Diagnostic Chemicals , Ltd. CJY Class II 2005-11-10
K052148 TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET Reference Diagnostics, Inc. JIT Class II 2005-11-09
K051804 ABL80 FLEX ANALYZER Sendx Medical, Inc. CHL Class II 2005-11-01
K052982 ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET Roche Diagnostics JIT Class II 2005-10-28
K051727 AIMSTICK URINE REAGENT STRIPS Germaine Laboratories, Inc. CEN Class I 2005-10-26
K051452 SENTINEL CLIN CHEM CAL Sentinel Ch. Srl JIX Class II 2005-10-25
K052121 GEM PREMIER 3000 Instrumentation Laboratory CO CGA Class II 2005-10-21
K051888 TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 Scantibodies Laboratory, Inc. CEW Class II 2005-10-18
K051543 ELECSYS PRECICONTROL BONE Roche Diagnostics Corp. JJY Class I 2005-10-17
K051928 AUTOCHECK6+ Radiometer Medical Aps JJY Class I 2005-10-12
K052163 ADVIA IMS GLUCOSE ASSAY Bayer Healthcare, LLC CFR Class II 2005-10-11
K051646 ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH Pointe Scientific, Inc., JGS Class II 2005-10-07
K050985 GLUCODR SUPERSENSOR SYSTEM All Medicus Co., Ltd. NBW Class II 2005-10-07
K051514 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 Hypoguard USA, Inc. NBW Class II 2005-10-04
K052010 HBA1C LINEARITY SET Cone Bioproducts JJX Class I 2005-10-04
K052359 IBL CORTISOL LIA TEST KIT Lehnus & Associates Consulting CGR Class II 2005-10-03
K051969 TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA Ibl GmbH CHQ Class I 2005-10-03
K052242 ADVIA CHEMISTRY MICROALBUMIN CONTROLS Bayer Healthcare, LLC JJW Class I 2005-10-03
K052193 ISE COMPENSATOR Roche Diagnostics JIT Class II 2005-10-03
K052027 OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 Osmetech, Inc. CGZ Class II 2005-09-29
K052056 DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM Thermo-Electron Corp. JJY Class I 2005-09-23
K051787 TRIAGE BNP TEST, MODEL 98000XR Biosite Incorporated NBC Class II 2005-09-22
K051810 WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 Scantibodies Laboratory, Inc. CEW Class II 2005-09-09
K051297 ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK Roche Diagnostics Corp. NEO Class II 2005-09-08
K051650 STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. Dade Behring, Inc. JHX Class II 2005-09-08
K051592 MODIFICATION TO ACCU-CHEK GO SYSTEM Roche Diagnostics Corp. LFR Class II 2005-09-02
K052017 CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 Dade Behring, Inc. MKW Class II 2005-09-01
K051962 ULTRA HDL Abbott Laboratories LBS Class I 2005-08-25
K051115 SENTINEL IRON LIQUID Sentinel Ch. Srl JIY Class I 2005-08-25
K051376 ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE Roche Diagnostics CHH Class I 2005-08-23
K051841 WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST W.H.P.M., Inc. JHI Class II 2005-08-22
K052002 IRON STANDARD Roche Diagnostics Corp. JIT Class II 2005-08-22
K050644 VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT Vancouver Biotech , Ltd. MMI Class II 2005-08-17
K051526 URITEK-720+ URINE ANALYZER Teco Diagnostics KQO Class I 2005-08-16
K050869 MODIFICATION TO ABL800 FLEX Radiometer Medical Aps CIG Class II 2005-08-11
K051802 FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. NBW Class II 2005-08-09
K050182 Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM Biomedix, Inc. CGA Class II 2005-08-09
K051936 CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS Taidoc Technology Corporation NBW Class II 2005-08-08
K051121 DIRECT LDL CHOLESTEROL, MODEL L530-60H Teco Diagnostics MRR Class I 2005-08-08
K051854 CLEVER CHEK TD-4225, MODEL TD-4225 Taidoc Technology Corporation NBW Class II 2005-08-05
K051327 ABBOTT AXSYM B12 Abbott Laboratories CDD Class II 2005-08-03
K051285 GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM Infopia Co, Ltd. CGA Class II 2005-08-02
K051619 LIPOPROTEIN FOR MULTIPLE ANALYTES Bayer Healthcare, LLC JIX Class II 2005-08-01
K050823 DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR Teco Diagnostics LBR Class I 2005-07-26
K051150 TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT Scantibodies Laboratory, Inc. CEW Class II 2005-07-26
K051141 WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 Scantibodies Laboratory, Inc. CEW Class II 2005-07-26
K051019 SAFETY NEEDLE Sarstedt, Inc. JKA Class II 2005-07-25
K051687 ELECSYS PRECICONTROL UNIVERSAL Roche Diagnostics Corp. JJY Class I 2005-07-25
K051457 SENTINEL PLASMAPROTEINS CAL 3X Sentinel Ch. Srl JIX Class II 2005-07-25
K051012 PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. Salimetrics, LLC JIT Class II 2005-07-19
K050224 3TEST GLUCOSE MONITORING SYSTEM Neuero Engineering, Inc. NBW Class II 2005-07-13
K051147 SIDEKICK BLOOD GLUCOSE TEST SYSTEM Home Diagnostics, Inc. NBW Class II 2005-07-12
K051752 ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) Roche Diagnostics MMI Class II 2005-07-11
K050960 MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT Wallac OY JLX Class I 2005-07-11
K051087 DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc. JJE Class I 2005-07-11
K051108 PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM Abaxis, Inc. CFJ Class II 2005-07-08
K051110 1,25-DIHYDROXY VITAMIN D EIA Immunodiagnostic Systems , Ltd. MRG Class II 2005-07-06
K042522 JAUNDICE METER, MODEL JM 103 Draeger Medical Infant Care, Inc. MQM Class I 2005-07-06
K051185 ELECSYS CA 19-9 CALCHECK Roche Diagnostics Corp. JJY Class I 2005-07-06
K050231 ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET Roche Diagnostics Corp. JIT Class II 2005-07-06
K051517 ELECSYS PRECICONTROL ANEMIA Roche Diagnostics Corp. JJY Class I 2005-07-05
K050283 CREATININE LIQUICOLOR Stanbio Laboratory JFY Class II 2005-06-30
K050266 DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR Stanbio Laboratory JFM Class II 2005-06-30
K050500 FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. NBW Class II 2005-06-27
K051292 ELECSYS RBC FOLATE HEMOLYZED REAGENT Roche Diagnostics Corp. CGN Class II 2005-06-17
K051432 SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS Arkray, Inc. CIG Class II 2005-06-17
K051265 ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY Bayer Healthcare, LLC NBC Class II 2005-06-13
K050790 SPOTCHEM II LDH TEST Arkray, Inc. CFH Class II 2005-06-06
K043340 EZ SMART Vip Diagnostics, LLC NBW Class II 2005-06-02
K050784 NICHOLS ADVANTAGE ALDOSTERONE ASSAY Nichols Institute Diagnostics CJM Class II 2005-06-01
K051213 PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS Abbott Laboratories, Inc. NBW Class II 2005-05-27
K050632 ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY Bayer Healthcare, LLC LBS Class I 2005-05-26
K050305 ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 Bioscreen Medical, Inc. LCX Class II 2005-05-23
K043197 ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. CGA Class II 2005-05-20
K050748 ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 Scantibodies Laboratory, Inc. CKG Class II 2005-05-20
K050546 ACON +/- MIDSTREAM PREGNANCY TEST ACON Laboratories, Inc. LCX Class II 2005-05-20
K050983 IRMA TRUPOINT CREATININE CONTROL KIT International Technidyne Corporation JJX Class I 2005-05-16
K050741 IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT Ind Diagnostic, Inc. JHI Class II 2005-05-16

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