| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 (K072054) | Bionime Corporation | 2008-02-28 |
| CALCIUM, SCAL, NORTROL, ABTROL (K073355) | Thermofisher Scientific OY | 2008-02-28 |
| ELECSYS PROBNP II CALCHECK (K080147) | Roche Diagnostics Corp. | 2008-02-27 |
| DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (K073072) | Dade Behring, Inc. | 2008-02-21 |
| EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT (K072249) | Medica Corp. | 2008-02-20 |
| AFINION ACR AND ACR CONTROL (K072409) | Axis-Shield Poc AS | 2008-02-12 |
| ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET (K072437) | Roche Diagnostics | 2008-02-05 |
| PATHFAST NTPROBNP AND D-DIMER TESTS (K072189) | Mitsubishi Kagaku Iatron | 2008-02-05 |
| BS-200 CHEMISTRY ANALYZER, MODE BS-200 (K072018) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-02-01 |
| DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) (K072270) | Diazyme Laboratories | 2008-02-01 |
| WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM (K073573) | Agamatrix | 2008-01-30 |
| ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE (K062534) | Drg Intl., Inc. | 2008-01-29 |
| QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K073080) | Bio-Rad Laboratories | 2008-01-24 |
| CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER (K072166) | The Binding Site | 2008-01-24 |
| DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (K072523) | General Atomics | 2008-01-22 |
| DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (K073055) | Dade Behring, Inc. | 2008-01-03 |
| DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS (K072395) | Diazyme Laboratories | 2008-01-03 |
| CHOLESTRAK HDL CHOLESTEROL HOME TEST (K072836) | Accutech, LLC | 2007-12-27 |
| IRISPEC,CA/CB/CC (K072640) | Iris Diagnostics | 2007-12-21 |
| PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM (K072784) | Taidoc Technology Corporation | 2007-12-21 |
| ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) (K071706) | Clinical Data, Inc. | 2007-12-20 |
| ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C (K071930) | Blue Cross Bio-Medical Co., Ltd. | 2007-12-18 |
| VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 (K063243) | bioMerieux, Inc. | 2007-12-14 |
| DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 (K072717) | Dade Behring, Inc. | 2007-12-12 |
| LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK (K072835) | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 (K073157) | Ortho-Clinical Diagnostics, Inc. | 2007-12-07 |
| ADVIA CHEMISTRY TOTAL BILIRUBIN_2 (K063845) | Bayer Healthcare, LLC | 2007-12-07 |
| TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 (K072892) | Biosite Incorporated | 2007-12-07 |
| FASTPACK HCG IMMUNOASSAY (K072264) | Qualigen, Inc. | 2007-12-06 |
| MICROPROTEIN REAGENT SET (K070757) | Pointe Scientific, Inc., | 2007-12-04 |
| CREATININE (ENZYMATIC) (K070824) | Thermofisher Scientific OY | 2007-12-03 |
| EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 (K070053) | Eps Bio Technology Corp. | 2007-12-03 |
| SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH (K072783) | Smiths Medical Asd, Inc. | 2007-11-30 |
| ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H (K072115) | Horiba Abx | 2007-11-30 |
| DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR (K071224) | Dade Behring, Inc. | 2007-11-13 |
| ACCESSA CHOLESTEROL PANEL (K063852) | Home Access Health Corp. | 2007-11-09 |
| GENTIAN CYSTATIN C IMMUNOASSAY (K071388) | Gentian AS | 2007-11-06 |
| THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS (K070984) | Abbott Diabetes Care, Inc. | 2007-11-01 |
| CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 (K071493) | Taidoc Technology Corporation | 2007-10-26 |
| QUANTRX FEMALE FERTILITY TEST (K070484) | Quantrx Biomedical Corporation | 2007-10-22 |
| AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER (K062932) | Ahlstrom Mount Holly Springs, LLC | 2007-10-19 |
| ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (K072638) | Roche Diagnostics Corp. | 2007-10-19 |
| DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H (K072435) | Dade Behring, Inc. | 2007-10-17 |
| PTS PANELS CHOL+HDL PANEL TEST STRIPS (K071593) | Polymer Technology Systems, Inc. | 2007-10-15 |
| AMNISCREEN HOME DETECTION LINER KIT (K071100) | Common Sense , Ltd. | 2007-10-15 |
| ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP (K070146) | Horiba Abx | 2007-10-12 |
| MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (K071934) | Biomet Manufacturing Corp | 2007-10-11 |
| VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST (K070597) | Nanosphere, Inc. | 2007-10-11 |
| ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS (K072204) | Siemens Medical Solutions Diagnostics | 2007-10-05 |
| CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL (K071340) | Thermofisher Scientific OY | 2007-10-05 |
| ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM (K072543) | Lifescan, Inc. | 2007-10-05 |
| ELECSYS CORTISOL TEST SYSTEM (K070788) | Roche Diagnostics | 2007-10-05 |
| ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F (K072039) | Taidoc Technology Corporation | 2007-10-03 |
| AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (K071580) | Thermofisher Scientific OY | 2007-10-03 |
| LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 (K071480) | DiaSorin, Inc. | 2007-10-01 |
| MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM (K072413) | Agamatrix | 2007-09-27 |
| VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (K072443) | Ortho-Clinical Diagnostics, Inc. | 2007-09-24 |
| IMMULISA INTRINSIC FACTOR ANTIBODY ELISA (K071346) | Immco Diagnostics, Inc. | 2007-09-24 |
| REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM (K072489) | Taidoc Technology Corporation | 2007-09-20 |
| VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) (K072440) | Ortho-Clinical Diagnostics, Inc. | 2007-09-20 |
| DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL (K071971) | Diazyme Laboratories | 2007-09-17 |
| VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 (K072246) | Maine Standards Co. | 2007-09-14 |
| TOTAL PROTEIN URINE/CSF GEN.3 (K071239) | Roche Diagnostics | 2007-09-14 |
| ARCHITECT STAT TROPONIN-1; MYOGLOBIN (K070640) | Fisher Diagnostics | 2007-09-13 |
| DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H (K071980) | Dade Behring, Inc. | 2007-09-11 |
| PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS (K071507) | Polymer Technology Systems, Inc. | 2007-09-10 |
| ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER (K070531) | Thermo Fisher Scientific | 2007-09-04 |
| EASYRA CLINICAL CHEMISTRY ANALYZER (K070057) | Medica Corp. | 2007-08-30 |
| EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS (K071648) | Canterbury Scientific , Ltd. | 2007-08-22 |
| OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 (K070708) | Olympus Life & Material Science Europa GmbH (Irish | 2007-08-21 |
| STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM (K071834) | Dade Behring, Inc. | 2007-08-17 |
| GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM (K063771) | Arkray Factory USA, Inc. | 2007-08-09 |
| MISSION OLYMPUS AU ISE CALIBRATORS (K071039) | Diamond Diagnostics, Inc. | 2007-08-08 |
| DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A (K071767) | Dade Behring, Inc. | 2007-08-04 |
| ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (K070727) | Siemens Medical Solutions Diagnostics | 2007-08-03 |
| ARCHITECT TACROLIMUS: MODEL 1L77 (K070820) | Fujirebio Diagnostics,Inc. | 2007-08-01 |
| ACON U120 URINE ANALYZER, MODEL U111-101 (K070929) | ACON Laboratories, Inc. | 2007-07-30 |
| COBAS C 111 ANALYZER (K071211) | Roche Diagnostics | 2007-07-30 |
| ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY (K071587) | Inverness Medical Innovations, Inc. | 2007-07-30 |
| ONE STEP HCG PREGNANCY TEST (K062703) | Ai DE Diagnostic Co., Ltd. | 2007-07-23 |
| VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 (K071801) | Ortho-Clinical Diagnostics, Inc. | 2007-07-20 |
| JAZZ BLOOD GLUCOSE MONITORING SYSTEM (K071393) | Agamatrix | 2007-07-20 |
| ROCHE ELECSYS PTH TEST SYSTEM (K070709) | Roche Diagnostics Corp. | 2007-07-13 |
| TRILOGY ANALYZER (K070704) | Drew Scientific, Inc. | 2007-07-13 |
| POINTE 360 (K062118) | Pointe Scientific, Inc., | 2007-07-13 |
| NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM (K070960) | Nova Biomedical Corp. | 2007-07-11 |
| MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES (K063357) | Greiner Bio-One North America, Inc. | 2007-07-10 |
| MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 (K062377) | Medapps, Inc. | 2007-07-03 |
| LIQUICHEK TUMOR MARKER CONTROL (K071675) | Bio-Rad Laboratories | 2007-07-03 |
| BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC (K071030) | Applied Dna Technologies, Inc. | 2007-06-29 |
| POLYMAP PWR-08-03 (K070559) | Polymap Wireless | 2007-06-29 |
| BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG (K070921) | Applied Dna Technologies, Inc. | 2007-06-29 |
| SMS GLUCOSE CONTROL, MODEL 2120059 (K071433) | Specialty Medical Supplies | 2007-06-28 |
| EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER (K063376) | Medica Corp. | 2007-06-25 |
| MICRODOT BLOOD GLUCOSE MONITORING SYSTEM (K070524) | Cambridge Sensors Limited | 2007-06-22 |
| ENZYMATIC CREATININE ASSAY (265 SERIES) (K070383) | Diagnostic Chemicals , Ltd. | 2007-06-22 |
| ST AIA-PACK INTACT PTH ASSAY (K063605) | Tosoh Bioscience, Inc. | 2007-06-21 |
| CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 (K070941) | Taidoc Technology Corporation | 2007-06-21 |
| GENESISCS COMPONENT CONCENTRATING SYSTEM (K070666) | Perfusion Partners & Assoc., Inc. | 2007-06-20 |
| ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 (K063232) | Biokit, S.A. | 2007-06-19 |