| EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM (K113243) | Eps Bio Technology Corp. | 2012-03-28 |
| GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL (K113547) | Apex BioTechnology Corp. | 2012-03-28 |
| CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) (K110587) | Bayer Healthcare, LLC | 2012-03-28 |
| CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (K110894) | Bayer Healthcare | 2012-03-28 |
| BIOLIS 12I (K110520) | Tokyo Boeki Medisys, Inc. | 2012-03-23 |
| BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER (K112377) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-03-23 |
| ABL90 FLEX (K120197) | Radiometer Medical Aps | 2012-03-19 |
| DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION (K103329) | Delbio Incorporation | 2012-03-13 |
| AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM (K103116) | Bestgen Biotech Corp. | 2012-03-13 |
| MICT TSH (K110761) | Magnabiosciences, LLC | 2012-03-09 |
| NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS (K112638) | Nova Biomedical Corporation | 2012-03-09 |
| LIASYS 450 (K113131) | Ams | 2012-03-08 |
| FORESIGHT U120 URINE ANALYZER (K120124) | ACON Laboratories, Inc. | 2012-03-06 |
| CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM (K111268) | Bayer Healthcare | 2012-03-06 |
| AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY (K111964) | Aalto Scientific, Ltd. | 2012-03-02 |
| MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM (K111456) | Tianjin Empecs Medical Device Co., Ltd. | 2012-02-28 |
| BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (K113007) | Bionime Corporation | 2012-02-27 |
| FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS (K111874) | Abbott Laboratories | 2012-02-16 |
| IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... (K111938) | Immunodiagnostic Systems , Ltd. | 2012-02-14 |
| AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION (K103044) | Bestgen Biotech Corp. | 2012-02-10 |
| DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM (K113343) | Delbio Incorporation | 2012-02-08 |
| FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM (K111890) | Taidoc Technology Corporation | 2012-02-06 |
| ROTOR-GENE Q MDX (K113319) | QIAGEN GmbH | 2012-02-06 |
| IDS-ISYS INTACT PTH (K103325) | Immunodiagnostic Systems , Ltd. | 2012-02-03 |
| AUDIT MICROCV T-UPTAKE LINEARITY (K112143) | Aalto Scientific, Ltd. | 2012-01-31 |
| GLUCOSE METER-CHECK SOLUTION FOR INFOPIA (K113764) | Bionostics, Inc. | 2012-01-30 |
| MICRODOT & MICRODOT XTRA (K102383) | Cambridge Sensors Limited | 2012-01-27 |
| VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT (K113524) | Maine Standards Co. | 2012-01-27 |
| GAL-1A BLOOD GLUCOSE MONITORING SYSTEM (K113208) | Apex BioTechnology Corp. | 2012-01-26 |
| AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL (K112705) | Aalto Scientific, Ltd. | 2012-01-24 |
| RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 (K110534) | Randox Laboratories Limited | 2012-01-23 |
| LIAISON 25 OH VITAMIN D TOTAL ASSAY (K112725) | DiaSorin, Inc. | 2012-01-20 |
| AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. (K112161) | Radiometer Medical Aps | 2012-01-20 |
| AG-608N BLOOD GLUCOSE MONITORING SYSTEM (K110017) | Andon Medical Co., Ltd. | 2012-01-18 |
| AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III (K113098) | Apex BioTechnology Corp. | 2012-01-17 |
| AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION (K100437) | Bestgen Biotech Corp. | 2012-01-12 |
| GLUCOSE TEST SYSTEM (K113137) | Roche Diagnostics | 2012-01-06 |
| NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (K112955) | Nova Biomedical Corporation | 2012-01-05 |
| DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL (K113373) | Siemens Healthcare Diagnostics, Inc. | 2011-12-30 |
| ELITTECH CLINICAL SYSTEMS ALP IFCC SL (K113269) | Elitechgroup | 2011-12-29 |
| GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT (K112352) | Bionostics, Inc. | 2011-12-23 |
| EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K112901) | Eps Bio Technology Corp. | 2011-12-23 |
| AU5800(R) CHEMISTRY ANALYZER (K112412) | Beckman Coulter, Inc. | 2011-12-23 |
| FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K101926) | Taidoc Technology Corporation | 2011-12-20 |
| I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (K112430) | Abbott Pont of Care, Inc. | 2011-12-20 |
| ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) (K112443) | Axis-Shield Diagnostics, Ltd. | 2011-12-19 |
| FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM (K112275) | Taidoc Technology Corporation | 2011-12-15 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE (K111753) | Hitachi Chemical Diagnostics, Inc. | 2011-12-14 |
| PRESAGE ST2 ASSAY (K111452) | Critical Care Diagnostics, Inc. (Dba Critical Diag | 2011-12-09 |
| IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D (K103544) | Agamatrix, Inc. | 2011-12-07 |
| ESENSOR WARFARIN SENSITIVITY SALIVA TEST (K110786) | GenMark Diagnostics, Inc. | 2011-12-02 |
| MAGNESIUM ASSAY (K111915) | Sekisui Diagnostics P.E.I., Inc. | 2011-12-02 |
| ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 (K110701) | DNA Genotek, Inc. | 2011-12-02 |
| PRESTIGE 24I; BIOLIS 24I; MGC 240 (K103531) | Tokyo Boeki Medisys, Inc. | 2011-12-01 |
| ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 (K111335) | Tosoh Bioscience, Inc. | 2011-12-01 |
| RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL (K112337) | Randox Laboratories, Ltd. | 2011-12-01 |
| ROM PLUS (K110605) | Clinical Innovations, LLC | 2011-11-23 |
| ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS (K110619) | Biokit, S.A. | 2011-11-23 |
| TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS (K112963) | Taidoc Technology Corporation | 2011-11-22 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM (K112999) | Siemens Healthcare Diagnostics | 2011-11-22 |
| ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS (K111960) | Elitechgroup | 2011-11-18 |
| ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL (K103376) | Seppim S.A.S. | 2011-11-18 |
| IGLUCOSE SYSTEM (K111932) | Positiveid Corporation | 2011-11-10 |
| SWEETSPOT DIABETES DATA MANAGEMENT SERVICE (K111509) | Sweetspot Diabetes Care, Inc. | 2011-11-09 |
| ASIMANAGER - AT (K111356) | Arlington Scientific, Inc. | 2011-11-09 |
| CPK REAGENT (K112416) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-11-09 |
| PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT (K103788) | HORIBA ABX SAS | 2011-11-08 |
| IT/IF CONTROL (K101863) | Sebia | 2011-11-07 |
| ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS (K112603) | Beckman Coulter, Inc. | 2011-11-04 |
| POLY-CHEM 90 ISE MODULE (K112408) | Polymedco, Inc. | 2011-11-04 |
| ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K103021) | Infopia Co, Ltd. | 2011-11-04 |
| THERMO SCIENTIFIC MAS OMNI-CORE (K110738) | Microgenics Corporation | 2011-11-03 |
| ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION (K103278) | I-Sens, Inc. | 2011-10-28 |
| EASTLYTE NA/K/CA/PH (K112788) | Medica Corp. | 2011-10-20 |
| ELECSYS T4 CALCHECK 5 (K112528) | Roche Diagnostics Corporation | 2011-10-18 |
| ADVIA CENTAUR VITAMIN D TOTAL ASSAY (K110586) | Siemens Healthcare Diagnostics, Inc. | 2011-10-14 |
| PRODIGY DIABETES MANAGEMENT SOFTWARE (K103115) | Prodigy Diabetes Care, LLC | 2011-10-12 |
| HEALTH-E-CONNECT SYSTEM (K102063) | Alr Technologies | 2011-10-11 |
| GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM (K102316) | Broadmaster Biotech Corporation | 2011-10-07 |
| ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II (K110780) | Elitechgroup | 2011-10-07 |
| ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM (K111371) | ACON Laboratories, Inc. | 2011-10-06 |
| ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS (K110579) | Abbott Laboratories | 2011-10-06 |
| FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST (K103487) | Taidoc Technology Corporation | 2011-10-04 |
| ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE (K112738) | Andon Medical Co., Ltd. | 2011-09-30 |
| RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 (K110904) | Randox Laboratories, Ltd. | 2011-09-30 |
| RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (K110846) | Randox Laboratories Limited | 2011-09-30 |
| NMR LIPOPROFILE (R) TEST AND NMR PROFILER (K111516) | Liposcience, Inc. | 2011-09-27 |
| COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION (K103396) | I-Sens, Inc. | 2011-09-27 |
| EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM (K110435) | U. S. Diagnostics, Inc. | 2011-09-21 |
| CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL (K110061) | Siemens Healthcare Diagnostics | 2011-09-21 |
| ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM (K101299) | Roche Diagnostics | 2011-09-21 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE (K112356) | Bionostics, Inc. | 2011-09-19 |
| DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM (K100806) | Delbio Incorporation | 2011-09-16 |
| EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K111728) | Eps Bio Technology Corp. | 2011-09-16 |
| GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS (K102816) | Apex BioTechnology Corp. | 2011-09-15 |
| ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 (K111996) | Elitechgroup | 2011-09-14 |
| ELECSYS MYOGLOBIN CALCHECK 5 (K112113) | Roche Diagnostics | 2011-09-14 |
| ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD (K103615) | Alfa Wassermann Diagnostic Technologies, Inc. | 2011-09-08 |
| POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS (K110818) | Polymedco, Inc. | 2011-09-08 |
| ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM (K110637) | Cilag GmbH International | 2011-09-07 |