| SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 (K091153) | Beckman Coulter, Inc. | 2009-07-13 |
| NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 (K083130) | Perkinelmer, Inc. | 2009-07-09 |
| ELECSYS PRECICONTROL UNIVERSAL (K090541) | Roche Diagnostics | 2009-07-02 |
| VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET (K091225) | Maine Standards Co. | 2009-06-25 |
| BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD (K090109) | Epocal, Inc. | 2009-06-24 |
| FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 (K090404) | Taidoc Technology Corporation | 2009-06-23 |
| ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS (K082340) | Roche Diagnostics Corp. | 2009-06-19 |
| RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST (K081150) | Turklab Medical Devices, Inc. | 2009-06-16 |
| FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) (K083716) | Church & Dwight Co., Inc. | 2009-06-08 |
| CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 (K090283) | Genchem, Inc. | 2009-06-05 |
| EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS (K090629) | Tyson Bioresearch, Inc. | 2009-06-04 |
| HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI (K090737) | Bio-Rad Laboratories, Inc. | 2009-06-03 |
| POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 (K090588) | Beckman Coulter, Inc. | 2009-05-27 |
| ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 (K090943) | American Biological Technologies, Inc. | 2009-05-27 |
| DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 (K090330) | Siemens Healthcare Diagnostics, Inc. | 2009-05-22 |
| TEARLAB OSMOLARITY SYSTEM (K083184) | Ocusense, Inc. | 2009-05-14 |
| FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 (K090187) | Taidoc Technology Corporation | 2009-05-12 |
| ADVIA CENTAUR TSH3-ULTRA METHOD (K083844) | Siemens Healthcare Diagnostics | 2009-05-08 |
| ELECSYS RUBELLA IGG CALCHECK (K090311) | Roche Diagnostics | 2009-05-05 |
| GLUCODR AUTO SYSTEM (K083628) | All Medicus Co., Ltd. | 2009-05-01 |
| CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM (K090185) | Taidoc Technology Corporation | 2009-04-24 |
| ONE STEP HCG URINE/SERUM TEST (K072500) | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 |
| CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 (K083554) | Cliniqa Corporation | 2009-04-21 |
| ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 (K090854) | American Biological Technologies, Inc. | 2009-04-16 |
| AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K081922) | Wallac OY | 2009-04-16 |
| RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 (K083223) | Abbott Diabetes Care, Inc. | 2009-04-16 |
| VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 (K090475) | Maine Standards Co. | 2009-04-16 |
| AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 (K090043) | Apex BioTechnology Corp. | 2009-04-09 |
| ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM (K090057) | Acon Laboratories Co. | 2009-04-08 |
| CREATININE (K083809) | Abbott Laboratories | 2009-04-07 |
| ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) (K083386) | Siemens Healthcare Diagnostics | 2009-04-02 |
| TRUEBALANCE BLOOD GLUCOSE SYSTEM (K090495) | Home Diagnostics, Inc. | 2009-03-27 |
| FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247 (K090536) | Taidoc Technology Corporation | 2009-03-26 |
| BETACHEK GLUCOSE TEST (K062187) | National Diagnostic Products | 2009-03-24 |
| VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 (K083891) | Maine Standards Co. | 2009-03-23 |
| EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR (K080404) | Medica Corp. | 2009-03-13 |
| SYMCARE DIABETES MANAGEMENT PROGRAM (K083263) | Symcare Personalized Health Solutions, Inc. | 2009-03-13 |
| U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM (K083570) | Taidoc Technology Corporation | 2009-03-11 |
| ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 (K083906) | Siemens Healthcare Diagnostics | 2009-03-11 |
| DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (K083339) | Siemens Healthcare Diagnostics, Inc. | 2009-03-09 |
| VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 (K083680) | Ortho-Clinical Diagnostics, Inc. | 2009-02-27 |
| DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE (K083465) | Siemens Healthcare Diagnostics | 2009-02-27 |
| DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 (K083462) | Siemens Healthcare Diagnostics | 2009-02-27 |
| GLUCODR PLUS SYSTEM, MODEL AGM-3000 (K082328) | All Medicus Co., Ltd. | 2009-02-27 |
| ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (K082638) | Siemens Healthcare Diagnostics, Inc. | 2009-02-26 |
| G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A (K082201) | U. S. Diagnostics, Inc. | 2009-02-20 |
| DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM (K080853) | Genexel-Sein, Inc. | 2009-02-20 |
| DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 (K083579) | Siemens Healthcare Diagnostics | 2009-02-20 |
| EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT (K080874) | Medica Corp. | 2009-02-20 |
| DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 (K080636) | Hubdic Co., Ltd. | 2009-02-13 |
| ELECSYS TOXO IGG CALCHECK (K083655) | Roche Diagnostics | 2009-02-12 |
| CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) (K083468) | I-Sens, Inc. | 2009-02-10 |
| GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ (K082462) | Diamond Diagnostics, Inc. | 2009-02-06 |
| JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 (K083265) | Agamatrix, Inc. | 2009-02-03 |
| IMMULITE 2000 FREE T4 (K083373) | Siemens Healthcare Diagnostics, Inc. | 2009-02-02 |
| FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 (K082482) | Taidoc Technology Corporation | 2009-01-30 |
| EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM (K081796) | Eps Bio Technology Corp. | 2009-01-23 |
| EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 (K083099) | Eps Bio Technology Corp. | 2009-01-16 |
| CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (K081908) | Cliniqa Corporation | 2009-01-16 |
| COBAS INTEGRA 400/800 BILIRUBIN TOTAL (K081193) | Roche Diagnostics | 2009-01-16 |
| EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (K082521) | Card Guard Scientific Survival , Ltd. | 2009-01-16 |
| REAL-TIME PCR INTERNAL CONTROL 2B SET (K083430) | Nanogen, Inc. | 2009-01-15 |
| FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 (K083664) | Taidoc Technology Corporation | 2009-01-09 |
| AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 (K081767) | Amnisure International, LLC | 2009-01-09 |
| MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS (K081703) | Entra Health Systems, Ltd. | 2009-01-08 |
| ENVISION BLOOD GLUCOSE TEST SYSTEM (K082020) | Infopia Co, Ltd. | 2008-12-24 |
| ABT GLUCOSE CONTROL SOLUTION (K083549) | American Biological Technologies, Inc. | 2008-12-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM (K083173) | Ortho-Clinical Diagnostics | 2008-12-22 |
| FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM (K081715) | Taidoc Technology Corporation | 2008-12-17 |
| TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 (K082210) | Genzyme Diagnostics P.E.I., Inc. | 2008-12-16 |
| VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR (K081929) | Greiner Bio-One North America, Inc. | 2008-12-16 |
| EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT (K080810) | Medica Corp. | 2008-12-10 |
| PRO GLUCOSE TEST STRIP (K082169) | Taidoc Technology Corporation | 2008-12-04 |
| ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (K080485) | Diasys Diagnostics Systems GmbH | 2008-12-04 |
| RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) (K081975) | Abbott Diabetes Care, Inc. | 2008-11-26 |
| AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 (K082714) | Aalto Scientific, Ltd. | 2008-11-19 |
| EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT (K080823) | Medica Corp. | 2008-11-17 |
| CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA (K080623) | Jas Diagnostics, Inc. | 2008-11-17 |
| DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B (K082763) | Diazyme Laboratories | 2008-11-12 |
| ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT (K080294) | Astoria-Pacific, Inc. | 2008-11-04 |
| AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 (K082717) | Aalto Scientific, Ltd. | 2008-10-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM (K081543) | Ortho-Clinical Diagnostics, Inc. | 2008-10-23 |
| ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM (K082513) | Lifescan, Inc. | 2008-10-22 |
| GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 (K082417) | Arkray Factory USA, Inc. | 2008-10-21 |
| CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB (K080923) | I-Sens, Inc. | 2008-10-17 |
| A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY (K080851) | Anticancer, Inc. | 2008-10-10 |
| LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 (K082680) | Siemens Healthcare Diagnostics | 2008-10-10 |
| GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE (K082486) | Bayer Healthcare, LLC | 2008-10-08 |
| ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 (K082618) | Taidoc Technology Corporation | 2008-10-07 |
| RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS (K081478) | Bionostics, Inc. | 2008-10-06 |
| APPLIED BIOSYSTEMS 7500 FAST DX (K082562) | Applied Biosystems, Inc. | 2008-09-30 |
| DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 (K082645) | Siemens Healthcare Diagnostics | 2008-09-22 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 (K082395) | Bionostics, Inc. | 2008-09-18 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 (K081451) | Bionime Corporation | 2008-09-18 |
| S40 CREATINE KINASE (CK) (K082226) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-09-18 |
| CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 (K082107) | Cliniqa Corporation | 2008-09-17 |
| EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 (K082121) | Eps Bio Technology Corp. | 2008-09-17 |
| ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H (K081276) | Horiba Abx | 2008-09-12 |
| ARCHITECT CYCLOSPORINE (K080751) | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (K071455) | Siemens Medical Solutions Diagnostics | 2008-09-11 |