| ON CALL PLUS DIABETES MONITORING SOFTWARE (K101371) | ACON Laboratories, Inc. | 2011-01-07 |
| OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 (K093280) | Opti Medical Systems, Inc. | 2011-01-07 |
| AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 (K100715) | Aalto Scientific, Ltd. | 2010-12-23 |
| ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 (K103221) | Roche Diagnostics | 2010-12-23 |
| AUDIT MICROCV HS-CRP LINEARITY SET (K101427) | Aalto Scientific, Ltd. | 2010-12-23 |
| PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE (K100937) | I-Sens, Inc. | 2010-12-21 |
| LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS (K102700) | Alere, San Diego, Dba Biosite INcorporated, Dba IN | 2010-12-21 |
| DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (K103360) | Siemens Corp. | 2010-12-17 |
| GSP NEONATAL IRT KIT (3306-001U) (K102419) | Wallac Oy, Subsidiary of Perkinelmer | 2010-12-16 |
| ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 (K100525) | Seppim S.A.S. | 2010-12-15 |
| EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 (K100060) | Vital Diagnostics (Manufacturing) Ptyltd | 2010-12-15 |
| ABL837 FLEX ANALYZER (K100777) | Radiometer Medical Aps | 2010-12-10 |
| SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (K103340) | Harvest Technologies, Corp. | 2010-12-06 |
| PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH (K103099) | Roche Diagnostics | 2010-12-06 |
| DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS (K102638) | Diazyme Laboratories | 2010-11-30 |
| ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL (K102904) | Siemens Healthcare Diagnostics | 2010-11-23 |
| ELECSYS PTH CALCHECK 5 (K103162) | Roche Diagnostics | 2010-11-18 |
| BGM GALECTIN -3 (K093758) | Bg Medicine, Inc. | 2010-11-17 |
| VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR (K103041) | Greiner Bio-One North America, Inc. | 2010-11-09 |
| ELECSYS CA 125 II CALCHECK 5 (K102086) | Roche Diagnostics | 2010-11-01 |
| 3M INTEGRATED CYCLER (110V) & (220V) (K102314) | Focus Diagnostics, Inc. | 2010-10-29 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT (K101921) | Ortho-Clinical Diagnostics | 2010-10-22 |
| NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN (K102441) | Nano-Ditech Corporation | 2010-10-20 |
| NANO-CHECK AMI CTNI CARDIAC MARKER TEST (K102131) | Nano-Ditech Corporation | 2010-10-20 |
| WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 (K101597) | Agamatrix | 2010-10-18 |
| ELECSYS IGE CALCHECK 5 (K102269) | Roche Diagnostics | 2010-10-07 |
| ELECSYS CA 19-9 CALCHECK 5 (K101365) | Roche Diagnostics Corp. | 2010-10-05 |
| ELECSYS CEA CALCHECK 5 (K101856) | Roche Diagnostics | 2010-10-05 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 (K101809) | Fujirebio Diagnostics,Inc. | 2010-10-05 |
| K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (K093137) | Kamiya Biomedical Co. | 2010-09-28 |
| POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC (K100550) | Polymedco, Inc. | 2010-09-28 |
| FDI GLUCOSE CONTROL SOLUTIONS (K102260) | Fujirebio Diagnostics,Inc. | 2010-09-24 |
| AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- (K093883) | Seppim S.A.S. | 2010-09-20 |
| ST AIA-PACK CYSTATIN C, MODEL 025217 (K093960) | Tosoh Bioscience, Inc. | 2010-09-14 |
| LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK (K100727) | Bio-Rad, Diagnostics Grp. | 2010-09-14 |
| ELECSYS FERRITIN CALCHECK 5 (K102267) | Roche Diagnostics | 2010-09-10 |
| ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM (K101456) | Roche Diagnostics | 2010-09-08 |
| AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 (K100718) | Aalto Scientific, Ltd. | 2010-09-03 |
| PRECICONTROL CLINCHEM MULTI 1 AND 2 (K102016) | Roche Diagnostics | 2010-09-01 |
| ELECSYS DIGOXIN CALCHECK 5 (K102044) | Roche Diagnostics | 2010-08-31 |
| AUDIT MICROCV RF/CRP LINEARITY SET (K101226) | Aalto Scientific, Ltd. | 2010-08-31 |
| GELSCAN, MODEL 1206 (K100307) | Sebia | 2010-08-31 |
| ELECSYS PRECICONTROL MULTIMARKER (K102157) | Roche Diagnostics | 2010-08-27 |
| NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH (K101633) | Nova Biomedical Corp. | 2010-08-27 |
| RAPIDVUE HCG TEST (K102175) | Quidel Corporation | 2010-08-25 |
| NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U (K093916) | Perkinelmer, Inc. | 2010-08-23 |
| ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER (K092875) | Taidoc Technology Corporation | 2010-08-13 |
| AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS (K102037) | Apex BioTechnology Corp. | 2010-08-13 |
| FASTPACK TSH IMMUNOASSAY (K101390) | Qualigen, Inc. | 2010-08-13 |
| ABL90 FLEX SERIES (K092686) | Radiometer Medical Aps | 2010-08-06 |
| STA-HYBRID HEP CALIBRATOR (K092937) | Diagnostica Stago, Inc. | 2010-08-02 |
| FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION (K093724) | Taidoc Technology Corporation | 2010-07-29 |
| GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U (K100682) | Wallac OY | 2010-07-23 |
| AUDIT MICROCV PROCALCITONIN LINEARITY (K101434) | Aalto Scientific, Ltd. | 2010-07-22 |
| AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM (K093262) | Andon Medical Co., Ltd. | 2010-07-13 |
| IMPROVACUTER GEL & CLOT ACTIVATOR TUBE (K093910) | Guangzhou Improve Medical Instruments Co., Ltd. | 2010-07-12 |
| FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 (K100732) | Taidoc Technology Corporation | 2010-07-09 |
| LOCI 8 CALIBRATOR, MODEL KC 646 (K101460) | Siemens Healthcare Diagnostics | 2010-07-09 |
| FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM (K100405) | Taidoc Technology Corporation | 2010-07-09 |
| NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG (K093383) | bioMerieux, Inc. | 2010-07-06 |
| EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 (K101457) | Eps Bio Technology Corp. | 2010-07-01 |
| BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 (K101502) | Becton, Dickinson & CO | 2010-06-29 |
| TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 (K100322) | Taidoc Technology Corporation | 2010-06-28 |
| IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET (K091849) | Immunodiagnostic Systems, Inc. | 2010-06-25 |
| DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D (K093357) | Diamond Diagnostics, Inc. | 2010-06-24 |
| GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO (K093623) | Instrumentation Laboratory CO | 2010-06-18 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 (K092052) | Bionime Corporation | 2010-06-18 |
| FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 (K092638) | Abbott Diabetes Care, Inc. | 2010-06-15 |
| ELECSYS INSULIN CALCHECK 5 (K101075) | Roche Diagnostics Corp. | 2010-06-11 |
| GSP NEONATALGALT KIT, MODEL 3303-001U (K100101) | Perkinelmer, Inc. | 2010-06-11 |
| EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (K093297) | Epocal, Inc. | 2010-06-09 |
| ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) (K093819) | Arkray Factory USA, Inc. | 2010-06-09 |
| SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM (K100398) | Standard Diagnostics, Inc. | 2010-06-09 |
| ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 (K092705) | Abbott Molecular, Inc. | 2010-05-28 |
| GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 (K091168) | Infopia Co, Ltd. | 2010-05-27 |
| AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 (K100750) | Aalto Scientific, Ltd. | 2010-05-21 |
| FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System (K092602) | Abbott Diabetes Care, Inc. | 2010-05-14 |
| HDL CHOLESTEROL (HDLX) ASSAY (K100010) | Beckman Coulter, Inc. | 2010-05-14 |
| EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 (K100560) | Biotest Medical Corp. | 2010-05-12 |
| FORA V20 BLOOD GLUCOSE MONITORING SYSTEM (K100406) | Taidoc Technology Corporation | 2010-05-11 |
| ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 (K100289) | Siemens Healthcare Diagnostics | 2010-05-10 |
| DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A (K100778) | Siemens Healthcare Diagnostics | 2010-05-05 |
| EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT (K100187) | Medica Corp. | 2010-05-05 |
| FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM (K094005) | Taidoc Technology Corporation | 2010-05-05 |
| ILLUMINA BEADXPRESS SYSTEM (K093128) | Illumina, Inc. | 2010-04-28 |
| ELECSYS FOLATE III CALCHECK 5 (K094031) | Roche Diagnostics | 2010-04-27 |
| URITEST 50 AND URITEST 500 URINE ANALYZER (K091472) | Arj Medical, Inc. | 2010-04-27 |
| ELECSYS C-PEPTIDE CALCHECK 5 (K100810) | Roche Diagnostics | 2010-04-26 |
| SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER (K092911) | Diazyme Laboratories | 2010-04-26 |
| ELECSYS TESTOSTERONE II IMMUNOASSAY (K093421) | Roche Diagnostics Corp. | 2010-04-23 |
| ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 (K093940) | Taidoc Technology Corporation | 2010-04-23 |
| VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; (K093611) | Ortho-Clinical Diagnostics, Inc. | 2010-04-15 |
| ELECSYS TSH CALCHECK 5 (K093836) | Roche Diagnostics | 2010-04-15 |
| CONTREX PLUS LOW CONTROL SOLUTION (K100747) | Apex BioTechnology Corp. | 2010-04-14 |
| SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 (K100701) | Biotest Medical Corp. | 2010-04-08 |
| DIAZYME CYSTATIN C ASSAY (K093680) | Diazyme Laboratories | 2010-04-08 |
| EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 (K100673) | Medica Corp. | 2010-04-06 |
| COBAS U411 TEST SYSTEM (K093555) | Roche Diagnostics | 2010-04-02 |
| CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 (K093506) | Taidoc Technology Corporation | 2010-04-01 |
| ELECSYS TROPONIN I CALCHECK 5 (K100594) | Roche Diagnostics | 2010-04-01 |