| BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER (K092849) | Epocal, Inc. | 2010-03-30 |
| ELECSYS CK-MB CALCHECK 5 (K093582) | Roche Diagnostics | 2010-03-29 |
| CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 (K093941) | Taidoc Technology Corporation | 2010-03-26 |
| ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 (K093732) | Siemens Healthcare Diagnostics | 2010-03-22 |
| ELECSYS TROPONIN T CALCHECK 5 (K092848) | Roche Diagnostics Corp. | 2010-03-19 |
| ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 (K100293) | Siemens Heatlhcare Diagnostics, Inc. | 2010-03-19 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR (K093492) | Diamond Diagnostics, Inc. | 2010-03-19 |
| MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K091555) | Taidoc Technology Corporation | 2010-03-15 |
| DIDGET WORLD REPORTS (K093930) | Bayer Healthcare, LLC | 2010-03-12 |
| INTEGRATED LABORATORY AUTOMATION SOLUTION (K091975) | Integrated Laboratory Automation Solutions, Inc. | 2010-03-10 |
| MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) (K093384) | Diamond Diagnostics, Inc. | 2010-03-10 |
| ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 (K092740) | Abbott Laboratories | 2010-03-05 |
| NEONATAL BIOTINIDASE KIT, MODEL 3018 (K090123) | Perkinelmer, Inc. | 2010-03-05 |
| EXL ANEM CAL, MODEL RC640 (K093645) | Siemens Healthcare Diagnostics | 2010-03-05 |
| ELECSYS HCG STAT CALCHECK 5 (K093700) | Roche Diagnostics Corp. | 2010-03-04 |
| U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC (K092902) | Taidoc Technology Corporation | 2010-03-02 |
| SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM (K093764) | Biotest Medical Corp. | 2010-03-02 |
| ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 (K093592) | Taidoc Technology Corporation | 2010-02-25 |
| BASESENS BLOOD GLUCOSE MONITORING SYSTEM (K093475) | Hygeia, Inc. | 2010-02-24 |
| EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM (K092894) | Eps Bio Technology Corp. | 2010-02-24 |
| INTOUCH DIABETES (K093789) | Symcare Personalized Health Solutions, Inc. | 2010-02-19 |
| FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM (K093712) | Taidoc Technology Corporation | 2010-02-19 |
| ACCELERATOR APS (K093318) | Abbott Laboratories | 2010-02-19 |
| MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS (K093635) | Taidoc Technology Corporation | 2010-02-18 |
| B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 (K093631) | Siemens Healthcare Diagnostics | 2010-02-12 |
| FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 (K093005) | Taidoc Technology Corporation | 2010-02-05 |
| ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 (K092649) | Roche Diagnostics Corp. | 2010-02-04 |
| OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM (K090609) | Ok Biotech Co., Ltd. | 2010-02-04 |
| BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 (K093972) | Becton, Dickinson & CO | 2010-01-21 |
| EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM (K091765) | Visgeneer, Inc. | 2010-01-19 |
| NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS (K091547) | Nova Biomedical Corp. | 2010-01-15 |
| ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 (K091867) | Siemens Healthcare Diagnostics | 2010-01-14 |
| FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 (K093035) | Taidoc Technology Corporation | 2009-12-24 |
| AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (K093098) | Arkray, Inc. | 2009-12-23 |
| ELECSYS PROBNP II CALCHECK 5 (K092169) | Roche Diagnostics | 2009-12-16 |
| SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (K090940) | Astoria-Pacific, Inc. | 2009-12-14 |
| LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 (K093498) | DiaSorin, Inc. | 2009-12-14 |
| NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 (K092099) | Taidoc Technology Corporation | 2009-12-10 |
| SD CHECK GOLD (K082683) | Standard Diagnostics, Inc. | 2009-12-08 |
| DS-A BLOOD GLUCOSE MONITORING SYSTEM (K082965) | Alliance International Co., Ltd. | 2009-12-07 |
| SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 (K093458) | Beckman Coulter, Inc. | 2009-12-04 |
| COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY (K092603) | Roche Diagnostics | 2009-12-04 |
| DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 (K090628) | Bayer Healthcare, LLC | 2009-12-04 |
| MAS AND MINI-TROL PTH CONTROL (K092749) | Microgenics Corporation | 2009-12-03 |
| LIPIDPRO SYSTEM (K090405) | Infopia Co, Ltd. | 2009-12-01 |
| ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM (K092104) | Arkray Factory USA, Inc. | 2009-11-24 |
| ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL (K092993) | Siemens Healthcare Diagnostics | 2009-11-20 |
| FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE (K091814) | Taidoc Technology Corporation | 2009-11-20 |
| MICRODOT XTRA (K083273) | Cambridge Sensors Limited | 2009-11-19 |
| GLUCO LAB AUTO CODING, MODEL IGM-0022 (K091157) | Infopia Co, Ltd. | 2009-11-17 |
| EASYRA MG REAGENT, MODEL 10220 (K092737) | Medica Corp. | 2009-11-17 |
| SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 (K091815) | Biotest Medical Corp. | 2009-11-16 |
| ELECSYS HCG+B CALCHECK 5 (K092168) | Roche Diagnostics | 2009-11-16 |
| TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET (K093032) | Biosite Incorporated | 2009-11-13 |
| STA - FREE PS CALIBRATOR (K092113) | Diagnostica Stago, Inc. | 2009-11-13 |
| ELECSYS TOXO IGG CALCHECK 5 (K092888) | Roche Diagnostics Corp. | 2009-11-10 |
| OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (K091914) | Bionostics, Inc. | 2009-11-06 |
| ELECSYS PRECICONTROL THYROAB (K092320) | Roche Diagnostics | 2009-11-03 |
| ELECSYS RUBELLA IGGA CALCHECK 5 (K092585) | Roche Diagnostics | 2009-10-30 |
| S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) (K091413) | Alfa Wassermann, Inc. | 2009-10-26 |
| ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS (K091102) | Arkray Factory USA, Inc. | 2009-10-23 |
| EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 (K092887) | Eps Bio Technology Corp. | 2009-10-21 |
| POLY-CHEM 90 GLUCOSE (K090703) | Polymedco, Inc. | 2009-10-20 |
| SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 (K091846) | Beckman Coulter, Inc. | 2009-10-16 |
| ABX PENTRA TPU CAL, MODEL A11A01898 (K092570) | HORIBA ABX SAS | 2009-10-16 |
| POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM (K090653) | Arkray Factory USA, Inc. | 2009-10-09 |
| CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 (K091216) | Siemens Healthcare Diagnostics | 2009-10-09 |
| AIA-PACK RBC FOLATE (K091332) | Tosoh Bioscience, Inc. | 2009-10-02 |
| EOCENE SYSTEM (K090712) | Infopia Co, Ltd. | 2009-10-02 |
| PICCOLO MAGNESIUM TEST SYSTEM (K091910) | Abaxis, Inc. | 2009-10-01 |
| ELECYS ANTI-CCP CALCHECK (K091601) | Roche Diagnostics Corp. | 2009-09-25 |
| THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 (K092051) | Microgenics Corp. | 2009-09-21 |
| BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 (K091898) | Taidoc Technology Corporation | 2009-09-18 |
| EASYRA GLU-H REAGENT, MODEL 10200 (K092506) | Medica Corp. | 2009-09-16 |
| LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 (K090104) | DiaSorin, Inc. | 2009-09-09 |
| S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (K091544) | Alfa Wassermann, Inc. | 2009-09-09 |
| FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 (K092645) | Fujirebio Diagnostics,Inc. | 2009-09-05 |
| EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 (K091991) | Medica Corp. | 2009-09-04 |
| GSP INSTRUMENT AND GSP NEONATAL HTSH KIT (K090846) | Perkinelmer, Inc. | 2009-09-03 |
| VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 (K091861) | Ortho-Clinical Diagnostics, Inc. | 2009-09-03 |
| BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (K083744) | Binax, Inc. | 2009-09-01 |
| VS-SENSE TEST (K091287) | Common Sense , Ltd. | 2009-08-31 |
| ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND (K083867) | Beckman Coulter, Inc. | 2009-08-27 |
| CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM (K091820) | Bayer Healthcare | 2009-08-26 |
| BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 (K091292) | Becton, Dickinson and Company (BD) | 2009-08-25 |
| ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS (K082699) | Roche Diagnostics | 2009-08-19 |
| EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM (K091481) | Eps Bio Technology Corp. | 2009-08-18 |
| PATHFAST CK-MB-II, PATHFAST MYO-II (K081360) | Mitsubishi Kagaku Iatron | 2009-08-17 |
| ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 (K090332) | Arkray Factory USA, Inc. | 2009-08-14 |
| SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 (K091742) | Beckman Coulter, Inc. | 2009-08-14 |
| ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS (K091123) | Siemens Healthcare Diagnostics | 2009-08-14 |
| DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL (K091455) | Diazyme Laboratories | 2009-08-14 |
| ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 (K091460) | American Biological Technologies, Inc. | 2009-08-06 |
| S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (K091333) | Alfa Wassermann, Inc. | 2009-08-03 |
| AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (K083222) | Axis-Shield Diagnostics, Ltd. | 2009-07-31 |
| GLUCOMANAGER DATA MANAGEMENT SOFTWARE (K091229) | Eps Bio Technology Corp. | 2009-07-31 |
| EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES (K090734) | Medica Corp. | 2009-07-17 |
| POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 (K091296) | Polymap Wireless | 2009-07-17 |
| AP-1000 BLOOD GLUCOSE MONITORING SYSTEM (K090389) | Bestgen Biotech Corp. | 2009-07-14 |
| U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 (K090188) | Taidoc Technology Corporation | 2009-07-13 |