| FIA Blood Glucose Monitoring System (G2) (K131173) | Hmd Biomedical, Inc. | 2014-09-18 |
| RANDOX ALDOLASE CALIBRATION SERUM (K142181) | Randox Laboratories Limited | 2014-09-18 |
| GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System (K142336) | Arkray Factory, Inc. | 2014-09-17 |
| Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (K140496) | Beckman Coulter, Inc. | 2014-09-16 |
| IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM (K133584) | Eoshealth, Inc. | 2014-09-08 |
| GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM (K142035) | Arkray Factory, Inc. | 2014-09-05 |
| ELECSYS ESTRADIOL III CALCHECK 5 (K142127) | Roche Diagnostics | 2014-09-05 |
| NEPHROCHECK TEST SYSTEM (DEN130031) | Astute Medical, Inc. | 2014-09-05 |
| BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER (K140690) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014-09-02 |
| ACCU-CHEK Performa Blood Glucose Monitoring System (K133741) | Roche Diagnostics | 2014-08-29 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 (K140210) | Bionime Corporation | 2014-08-22 |
| STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE (DEN140016) | Dexcom, Inc. | 2014-08-19 |
| IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL (K141772) | Siemens Healthcare Diagnostics, Inc. | 2014-08-19 |
| OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM (K132633) | Ok Biotech Co., Ltd. | 2014-08-14 |
| Elecsys Estradiol III CalSet (K142021) | Roche Diagnostics | 2014-08-12 |
| DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS (K133751) | Diamond Diagnostics, Inc. | 2014-08-08 |
| GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION (K131230) | Philosys, Inc. | 2014-08-04 |
| TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM (K140100) | Nipro Diagnostics, Inc. | 2014-08-01 |
| ACE CALIBRATOR (K141728) | SENTINEL CH. SpA | 2014-07-28 |
| ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA (K133156) | Siemens Healthcare Diagnostics, Inc. | 2014-07-24 |
| ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT (K141265) | Elitechgroup | 2014-07-18 |
| COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET (K141143) | Roche Diagnostics | 2014-07-17 |
| SYSTEM CALIBRATER (K141388) | Beckman Coulter Ireland, Inc. | 2014-07-11 |
| ABX PENTRA MICRO ALB CONTROL L/H (K133676) | HORIBA ABX SAS | 2014-07-11 |
| IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL (K141444) | Siemens Healthcare Diagnostics, Inc. | 2014-07-09 |
| LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (K140141) | Ceragem Medisys, Inc. | 2014-07-03 |
| BICARBONATE CALIBRATOR (K141374) | Beckman Coulter Ireland, Inc. | 2014-06-30 |
| ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM (K124021) | Arkray Factory, Inc. | 2014-06-30 |
| MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM (K133260) | Tianjin Empecs Medical Device Co., Ltd. | 2014-06-27 |
| IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM (K132180) | Ideal Life, Inc. | 2014-06-25 |
| IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL (K133816) | Siemens Healthcare Diagnostics, Inc. | 2014-06-24 |
| CONTOUR NEXT EZ BLOOD GLUCOSE METER (K130265) | Bayer Healthcare, LLC | 2014-06-23 |
| LIQUICHEK TUMOR MARKER CONTROL (K141073) | Bio-Rad Laboratories | 2014-06-23 |
| CA 125 II CALSET II (K140112) | Roche Diagnostics | 2014-06-06 |
| URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (K131600) | Teco Diagnostics | 2014-05-29 |
| RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL (K140522) | Randox Laboratories Limited | 2014-05-22 |
| IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM (K133790) | Andon Health Co, Ltd. | 2014-05-22 |
| APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE (K141220) | Thermo Fisher Scientific (Life Technologies Holdin | 2014-05-22 |
| ISE INDIRECT NA, K, C1 FOR GEN 2 (K140373) | Roche Diagnostics | 2014-05-22 |
| BD VIPER LT SYSTEM (K140447) | Becton, Dickinson and Company | 2014-05-20 |
| CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR (K133519) | Carolina Liquid Chemistries Corp. | 2014-05-16 |
| XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK (K130915) | Jas Diagnostics, Inc. | 2014-05-15 |
| EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL (K130080) | Medica Corporation | 2014-05-13 |
| CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (K132711) | Carolina Liquid Chemistries Corp. | 2014-05-08 |
| ELECSYS CK-MB STAT IMMUNOASSAY (K140404) | Roche Diagnostics | 2014-05-08 |
| LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK (K140916) | Bio-Rad Laboratories | 2014-05-06 |
| IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C (K140818) | Siemens Healthcare Diagnostics, Inc. | 2014-05-01 |
| ACCU-CHEK AVIVA PLUS SYSTEM (K133862) | Roche Diagnostics Corporation | 2014-04-29 |
| GSP NEONATAL TOTAL GALACTOSE KIT (K133652) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014-04-28 |
| EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM (K133537) | Eps Bio Technology Corp. | 2014-04-28 |
| LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK (K140764) | Bio-Rad Laboratories | 2014-04-25 |
| LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO (K134013) | Bio-Rad Laboratories | 2014-04-24 |
| ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM (K132406) | Infopia Co, Ltd. | 2014-04-18 |
| UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) (K131189) | Beckman Coulter, Inc. | 2014-04-17 |
| RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM (K133522) | Bionime Coporation | 2014-04-17 |
| EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM (K133389) | Eps Bio Technology Corp. | 2014-04-15 |
| ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM (K133045) | Infopia Co, Ltd. | 2014-04-10 |
| ST AIA-PACK C-PEPTIDE II CALIBRATOR SET (K140648) | Tosoh Bioscience, Inc. | 2014-04-10 |
| WUNDER PREGNANCY TEST (K130456) | James Nguyen | 2014-04-08 |
| IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C (K140541) | Siemens Healthcare Diagnostics, Inc. | 2014-04-01 |
| ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL (K140505) | Siemens Healthcare Diagnostics, Inc. | 2014-03-31 |
| PATHFAST CTNL CALIBRATORS (K130603) | Mitsubishi Chemical Medience Corporation | 2014-03-27 |
| ELECSYS PRECICONTROL TS (K140534) | Roche Diagnostics | 2014-03-27 |
| RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 (K140393) | Randox Laboratories Limited | 2014-03-25 |
| NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM (K131703) | Nova Biomedical Corporation | 2014-03-25 |
| AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (K132031) | Axis-Shield Poc AS | 2014-03-21 |
| DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET (K133410) | Diazyme Laboratories | 2014-03-14 |
| FREND TSH (REAGENT CARTRIDGE) (K131928) | Nanoentek USA, Inc. | 2014-03-14 |
| S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (K140248) | Hitachi Chemical Diagnostics, Inc. | 2014-03-11 |
| ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) (K140267) | Siemens Healthcare Diagnostics, Inc. | 2014-03-10 |
| AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM (K131750) | Apex BioTechnology Corp. | 2014-03-06 |
| IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL (K140258) | Siemens Healthcare Diagnostics, Inc. | 2014-03-05 |
| CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (K131727) | Ceragem Medisys, Inc. | 2014-02-28 |
| HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS (K130255) | Abbott Laboratories | 2014-02-28 |
| EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM (K133647) | Eps Bio Technology Corp. | 2014-02-27 |
| ADVIA CENTAUR TESTOSTERONE (TSTO) (K133491) | Siemens Healthcare Diagnostics, Inc. | 2014-02-21 |
| EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO (K133509) | Biotest Medical Corp. | 2014-02-21 |
| VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT (K133550) | Maine Standards Company, LLC | 2014-02-05 |
| ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (K133601) | Siemens Healthcare Diagnostics, Inc. | 2014-02-05 |
| UA-CELLULAR COMPLETE (K131444) | Streck | 2014-01-29 |
| DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K132638) | Siemens Healthcare Diagnostics, Inc. | 2014-01-27 |
| ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (K131244) | Roche Diagnostics | 2014-01-27 |
| DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K133728) | Siemens Healthcare Diagnostics, Inc. | 2014-01-24 |
| AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 (K131580) | Tosoh Bioscience, Inc. | 2014-01-23 |
| LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL (K133960) | Bio-Rad Laboratories | 2014-01-22 |
| GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM (K123517) | Sd Biosensor | 2014-01-17 |
| FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE (K133197) | Fujirebio Diagnostics,Inc. | 2014-01-17 |
| IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL (K132739) | Siemens Healthcare Diagnostics, Inc. | 2014-01-14 |
| GEM PREMIER 4000 (K133407) | Instrumentation Laboratory CO | 2014-01-13 |
| FLEXMAP 3D (K133302) | Luminex Corp. | 2014-01-10 |
| RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT (K131554) | Randox Laboratories, Ltd. | 2014-01-09 |
| FASTEP S10 HCG SERUM/URINE COMBO TEST (K132834) | Polymed Therapeutics, Inc. | 2014-01-09 |
| ACTIM PROM (K123986) | Alere Scarborough, Inc. | 2014-01-09 |
| ACON ON CALL DIABETES MANAGEMENT SOFTWARE (K131469) | ACON Laboratories, Inc. | 2014-01-06 |
| ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL (K132399) | Elitechgroup | 2014-01-03 |
| LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) (K133512) | Siemens Healthcare Diagnostics | 2014-01-02 |
| FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM (K132511) | Abbott Diabetes Care, Inc. | 2013-12-24 |
| IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS (K123763) | Immunodiagnostic Systems , Ltd. | 2013-12-24 |
| ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM (K130284) | ACON Laboratories, Inc. | 2013-12-20 |
| ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM (K132086) | ACON Laboratories, Inc. | 2013-12-19 |