| NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 (K070255) | Nova Biomedical Corp. | 2007-06-13 |
| CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K062737) | Horiba Abx | 2007-06-12 |
| ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL (K060434) | Horiba Abx | 2007-06-05 |
| OLYMPUS CK-MB REAGENT (K070835) | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-04 |
| SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071280) | Beckman Coulter, Inc. | 2007-06-01 |
| SYNCHRON SYSTEMS CREATININE REAGENT (K071283) | Beckman Coulter, Inc. | 2007-06-01 |
| SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071277) | Beckman Coulter, Inc. | 2007-06-01 |
| MASSTRAK IMMUNOSUPPRESSANTS KIT (K063868) | Waters Corporation | 2007-05-25 |
| ACCU-CHEK PERFORMA SYSTEM (K070585) | Roche Diagnostics Corp. | 2007-05-25 |
| MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM (K070239) | Exir Pharmaceutical Co. | 2007-05-25 |
| VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 (K071216) | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 |
| VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 (K071215) | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 |
| MODIFICATION TO SENTINEL CLIN CHEM CAL (K070971) | Sentinel Ch. Srl | 2007-05-23 |
| AMYLASE EPS REAGENT (K070064) | Thermo Fisher Scientific | 2007-05-22 |
| ACCU-CHEK SMART PIX (K062395) | Roche Diagnostics Corp. | 2007-05-09 |
| KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST (K062096) | Koreamedico Co. , Ltd. | 2007-05-07 |
| TRACKRECORD DATA MANAGEMENT SOFTWARE (K070593) | Home Diagnostics, Inc. | 2007-05-07 |
| NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS (K070068) | Nova Biomedical Corp. | 2007-05-07 |
| CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 (K070741) | Cliniqa Corporation | 2007-05-04 |
| DBEST HCG PANEL TEST KIT (K061257) | Ameritek USA, Inc. | 2007-05-04 |
| FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST (K070054) | Church & Dwight Co., Inc. | 2007-05-04 |
| CARBON DIOXIDE LIQUID STABLE REAGENT (K070251) | Pointe Scientific, Inc., | 2007-04-30 |
| EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM (K062538) | Diacare Corp. | 2007-04-30 |
| DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) (K070552) | Dade Behring, Inc. | 2007-04-30 |
| ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H (K070249) | Horiba Abx | 2007-04-26 |
| LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X (K070848) | Bio-Rad, Diagnostics Grp. | 2007-04-25 |
| DIAZYME CREATININE LIQUID REAGENTS ASSAY (K062105) | Diazyme Laboratories | 2007-04-23 |
| SMS MULTI GLUCOSE CONTROL, MODEL 2120049 (K070506) | Medical Specialties Supply Co., Inc. | 2007-04-18 |
| MULTI-ANALYTE CHEMISTRY CALIBRATOR (K070207) | Pointe Scientific, Inc., | 2007-04-13 |
| SMS GLUCOSE CONTROL, MODEL 2120061 (K070649) | Spectrum Medical Supply, Inc. | 2007-04-12 |
| AMMONIA/ALCOHOL CONTROL SET (K070504) | Pointe Scientific, Inc., | 2007-04-11 |
| TECO HOMOCYSTEINE ENZYMATIC ASSAY (K063701) | Teco Diagnostics | 2007-04-11 |
| FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM (K070850) | Abbott Diabetes Care, Inc. | 2007-04-10 |
| ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 (K070641) | Taidoc Technology Corporation | 2007-04-09 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS (K063720) | Ortho-Clinical Diagnostics | 2007-04-09 |
| OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (K062862) | Olympus America, Inc. | 2007-04-06 |
| COMBI SCAN100 (K061846) | Analyticon Biotechnologies AG | 2007-04-06 |
| COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 (K061812) | Analyticon Biotechnologies AG | 2007-04-06 |
| FASTPACK TOTAL PSA METHOD VERIFICATION KIT (K062957) | Qualigen, Inc. | 2007-04-02 |
| CISBIO RENIN RIA TEST (K062120) | Cis Bio International | 2007-03-30 |
| APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (K061377) | Pointe Scientific, Inc., | 2007-03-28 |
| OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804) | Olympus America, Inc. | 2007-03-23 |
| THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 (K061412) | Thermo Electron Corp. | 2007-03-23 |
| ELECSYS PTH TEST SYSTEM (K070391) | Roche Diagnostics Corp. | 2007-03-20 |
| TDM CONTROL SET, MODEL CAT# 04521536 (K070200) | Roche Diagnostics Corp. | 2007-03-19 |
| DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE (K063756) | Dade Behring, Inc. | 2007-03-19 |
| OXALATE URINE CONTROLS (NORMAL AND ELEVATED) (K062521) | Thermo-Electron Corp. | 2007-03-16 |
| CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 (K070472) | Taidoc Technology Corporation | 2007-03-15 |
| AUDIT MICROCV LIPIDS LINEARITY SET (LOW) (K070223) | Aalto Scientific, Ltd. | 2007-03-13 |
| ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH (K060452) | Neo-Genesis | 2007-03-13 |
| CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH (K063647) | Thermo Electron OY | 2007-03-12 |
| VAP-NT CHOLESTEROL TEST (K062026) | Atherotech, Inc. | 2007-03-06 |
| URINE CHEMISTRY ANALYZER UR-50 (K063390) | Ind Diagnostic, Inc. | 2007-03-01 |
| DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH (K063608) | Dade Behring, Inc. | 2007-02-23 |
| WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (K061775) | Wako Chemicals USA, Inc. | 2007-02-23 |
| DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 (K063754) | Dade Behring, Inc. | 2007-02-23 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K062567) | Bionime Corporation | 2007-02-16 |
| ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM (K070088) | Apex BioTechnology Corp. | 2007-02-16 |
| OK METER BLOOD GLUCOSE MONITORING SYSTEM (K063026) | Ok Biotech Co., Ltd. | 2007-02-09 |
| GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM (K062799) | Apex BioTechnology Corp. | 2007-02-06 |
| INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS (K070144) | Beckman Coulter, Inc. | 2007-02-01 |
| LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 (K063855) | Liberty Healthcare Group, Inc. | 2007-02-01 |
| COBAS INTEGRA CERULOPLASMIN (K062379) | Roche Diagnostics Corp. | 2007-01-31 |
| PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS (K070017) | Polymer Technology Systems, Inc. | 2007-01-31 |
| TECO MICROALBUMIN 2-1 COMBO STRIPS (K061419) | Teco Diagnostics | 2007-01-26 |
| ACTIM PROM AND CONTROLS (K061886) | Medix Biochemica | 2007-01-25 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (K063821) | Nova Biomedical Corp. | 2007-01-24 |
| ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 (K060818) | Biokit, S.A. | 2007-01-23 |
| DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN (K063508) | Dade Behring, Inc. | 2007-01-23 |
| DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH (K063351) | Dade Behring, Inc. | 2007-01-22 |
| EUKARE (K062892) | Eumed Biotechnology Co., Ltd. | 2007-01-22 |
| CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (K062503) | Catachem, Inc. | 2007-01-19 |
| MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (K063208) | Diagnostic Chemicals , Ltd. | 2007-01-19 |
| COBAS INTEGRA C 111 (K063744) | Rochdiag | 2007-01-17 |
| LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 (K063409) | Agamatrix | 2007-01-12 |
| CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO (K062800) | Taidoc Technology Corporation | 2007-01-12 |
| EASYGLUCO, MODEL IGM-0002 G2 (K061431) | U. S. Diagnostics, Inc. | 2007-01-12 |
| CLINITEK ADVANTUS, MODEL 1420 (K063276) | Bayer Healthcare, LLC | 2006-12-28 |
| DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH (K063206) | Dade Behring, Inc. | 2006-12-28 |
| EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G (K062555) | Visgeneer, Inc. | 2006-12-27 |
| COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 (K063543) | Roche Diagnostics Corp. | 2006-12-22 |
| QUANTA LITE INTRINSIC FACTOR ELISA (K061841) | Inova Diagnostics, Inc. | 2006-12-22 |
| FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 (K063068) | Arkray USA, Inc. | 2006-12-20 |
| CORTISOL ELISA (K062626) | Ibl-Hamburg GmbH | 2006-12-20 |
| VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 (K062838) | Ortho-Clinical Diagnostics | 2006-12-19 |
| SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM (K061879) | Hemodiagnostica, LLC | 2006-12-15 |
| VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 (K063591) | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 |
| COPILOT HEALTH MANAGEMENT SYSTEM (K062770) | Abbott Diabetes Care, Inc. | 2006-12-14 |
| URITEST 10 URINALYSIS REAGENT STRIPS (K052719) | Arj Medical, Inc. | 2006-12-05 |
| MISSION TRINITY B (K062674) | Diamond Diagnostics, Inc. | 2006-12-01 |
| OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (K062581) | Olympus America, Inc. | 2006-11-29 |
| CALCIUM (K062855) | Abbott Laboratories | 2006-11-22 |
| ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM (K062347) | Bayer Healthcare, LLC | 2006-11-22 |
| AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 (K062467) | Axis-Shield Diagnostics, Ltd. | 2006-11-22 |
| CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET (K062593) | Compass Bioscience | 2006-11-22 |
| CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM (K063212) | Taidoc Technology Corporation | 2006-11-22 |
| VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (K063144) | Ortho-Clinical Diagnostics, Inc. | 2006-11-13 |
| ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 (K062434) | Agamatrix | 2006-11-13 |
| POLY-CHEM CREATININE (K061944) | Polymedco, Inc. | 2006-11-03 |
| STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ (K061830) | Nova Biomedical Corp. | 2006-11-01 |