| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 (K081450) | Bionime Corporation | 2008-09-11 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR (K081789) | Siemens Healthcare Diagnostics, Inc. | 2008-09-10 |
| LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK (K082036) | Bio-Rad Laboratories | 2008-09-08 |
| OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 (K080435) | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-05 |
| PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS (K080960) | Abbott Diabetes Care, Inc. | 2008-09-05 |
| OLYMPUS TOTAL BHCG TEST SYSTEN (K080094) | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-03 |
| ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 (K082141) | Biokit, S.A. | 2008-09-03 |
| DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 (K081731) | Siemens Healthcare Diagnostics | 2008-08-29 |
| TYSONBIO LINK HEALTH MANAGEMENT SYSTEM (K081726) | Tyson Bioresearch, Inc. | 2008-08-26 |
| ELECSYS ANTI-TSHR CALCHECK (K080643) | Roche Diagnostics | 2008-08-22 |
| MSC LIPID CONTROL (K082067) | Maine Standards Co. | 2008-08-22 |
| VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 (K082099) | Ortho-Clinical Diagnostics, Inc. | 2008-08-21 |
| GENTIAN CYSTATIN C IMMUNOASSAY (K081875) | Gentian AS | 2008-08-20 |
| TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 (K080641) | Home Diagnostics, Inc. | 2008-08-19 |
| TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 (K080710) | Home Diagnostics, Inc. | 2008-08-13 |
| FDTX GLUCOSE CONTROL SOLUTION (K081915) | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 |
| ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS (K080167) | Siemens Healthcare Diagnostics | 2008-08-08 |
| AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION (K080273) | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 |
| NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B (K071649) | Wallac OY | 2008-08-07 |
| U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM (K081957) | Taidoc Technology Corporation | 2008-08-05 |
| DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (K081992) | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 (K081319) | Siemens Healthcare Diagnostics, Inc. | 2008-08-04 |
| ABL 80 CO-OX SYSTEM (K080370) | Sendx Medical, Inc. | 2008-07-31 |
| CYTO-CHEX BCT (K080552) | Streck | 2008-07-31 |
| MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM (K080995) | Affymetrix, Inc. | 2008-07-30 |
| LIASYS WITH MODELS LIASYS (K080468) | Ams S.R.L. Analyzer Medical System | 2008-07-25 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK (K081403) | Bionostics, Inc. | 2008-07-25 |
| FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K081714) | Taidoc Technology Corporation | 2008-07-25 |
| NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS (K063841) | Liposcience | 2008-07-23 |
| SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING (K081229) | Smiths Medical Asd, Inc. | 2008-07-21 |
| AG-605 BLOOD GLUCOSE MONITORING SYSTEM (K073030) | Andon Health Co, Ltd. | 2008-07-21 |
| RAMP NT-PROBNP ASSAY (K063662) | Response Biomedical Corp. | 2008-07-21 |
| APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 (K080125) | Wako Chemicals USA, Inc. | 2008-07-18 |
| APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (K080123) | Wako Chemicals USA, Inc. | 2008-07-17 |
| DIAZYME APOLIPOPROTEIN A-1 ASSAY (K072977) | General Atomics | 2008-07-16 |
| ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K081389) | Roche Diagnostics | 2008-07-15 |
| S40 CLINICAL ANALYZER, S TEST ALB (K072143) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-07-14 |
| AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (K081345) | Thermogenesis Corp. | 2008-07-10 |
| LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 (K081683) | Siemens Healthcare Diagnostics | 2008-07-07 |
| IDEAL LIFE POD (MODEL ILP 0001) (K080538) | Ideal Life, Inc. | 2008-07-03 |
| DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 (K081643) | Siemens Healthcare Diagnostics | 2008-07-03 |
| CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 (K081609) | Taidoc Technology Corporation | 2008-07-02 |
| DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE (K081300) | Siemens Healthcare Diagnostics | 2008-07-02 |
| S-TEST CREATININE (CRE) (K080073) | Alfa Wassermann, Inc. | 2008-06-30 |
| VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K081411) | Ortho-Clinical Diagnostics, Inc. | 2008-06-30 |
| DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM (K072854) | Tyson Bioresearch, Inc. | 2008-06-30 |
| NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (K073537) | Siemens Medical Solutions Diagnostics | 2008-06-27 |
| IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM (K080283) | Taidoc Technology Corporation | 2008-06-27 |
| S-TEST C02 (K073223) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 |
| S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST (K072142) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 |
| SENTINEL PLASMAPROTEINS CAL 3X (K081533) | SENTINEL CH. SpA | 2008-06-25 |
| S-TEST CA (K072356) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU (K072140) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (K072141) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 (K081144) | Taidoc Technology Corporation | 2008-06-23 |
| TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET (K080811) | Roche Diagnostics Corp. | 2008-06-20 |
| MULTIGENT CREATININE (ENZYMATIC) ASSAY (K073634) | SENTINEL CH. SpA | 2008-06-19 |
| ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM (K073416) | Arkray Factory USA, Inc. | 2008-06-13 |
| ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM (K081318) | Lifescan, Inc. | 2008-06-09 |
| CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K080014) | Taidoc Technology Corporation | 2008-06-09 |
| TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (K080269) | Biosite Incorporated | 2008-06-06 |
| HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER (K080384) | The Binding Site, Ltd. | 2008-06-06 |
| CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC (K080973) | Cliniqa Corporation | 2008-06-02 |
| UREA/BUN, SCAL, NORTROL, ABTROL (K073295) | Thermofisher Scientific OY | 2008-05-29 |
| DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 (K081074) | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 |
| LOCI THYROID CALIBRATOR WITH MODEL RC610 (K081103) | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 |
| URIC ACID (AOX), SCAL, NORTROL, ABTROL (K073612) | Thermofisher Scientific OY | 2008-05-23 |
| DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA (K080578) | Siemens Healthcare Diagnostics, Inc. | 2008-05-16 |
| GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR (K080662) | Genzyme Corporation | 2008-05-15 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 (K080607) | Roche Diagnostics Corp. | 2008-05-12 |
| TC MATRIX CLINICAL CHEMISTRY ANALYZER (K073370) | Teco Diagnostics | 2008-05-08 |
| ESA BIOSCIENCES INC. VITAMIN D HPLC TEST (K072536) | Esa Biosciences, Inc. | 2008-05-07 |
| PROLYTE ELECTROLYTE ANALYZER (K070104) | Diamond Diagnostics, Inc. | 2008-05-07 |
| ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (K073640) | Axis-Shield Diagnostics, Ltd. | 2008-04-24 |
| SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 (K080501) | Taidoc Technology Corporation | 2008-04-21 |
| CREATINE KINASE LIQUID REAGENT, MODEL C519-440 (K072548) | Teco Diagnostics | 2008-04-18 |
| ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM (K073231) | Lifescan, Inc. | 2008-04-18 |
| 3TEST SUPREME GLUCOSE MONITORING SYSTEM (K072905) | Neuero Engineering, Inc. | 2008-04-18 |
| AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (K070889) | Wallac OY | 2008-04-14 |
| HDL CHOLESTEROL REAGENT, MODEL 10211 (K073497) | Medica Corp. | 2008-04-14 |
| GBI TSH NEONATAL SCREENING KIT (K072458) | Golden Bridge International, Inc. | 2008-04-10 |
| GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 (K073648) | Apex BioTechnology Corp. | 2008-04-10 |
| DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM (K073492) | Tyson Bioresearch, Inc. | 2008-04-08 |
| ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 (K063437) | Monobind, Inc. | 2008-04-04 |
| CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING (K073494) | Taidoc Technology Corporation | 2008-04-02 |
| GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 (K073137) | Apex BioTechnology Corp. | 2008-04-01 |
| MCT-DIABETES (K073699) | Mycare Team, Inc. | 2008-03-26 |
| EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM (K072441) | Tyson Bioresearch, Inc. | 2008-03-25 |
| EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM (K072369) | Hmd Biomedical, LLC | 2008-03-21 |
| ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 (K080166) | Beckman Coulter, Inc. | 2008-03-19 |
| ACTIVATED ASPARTATE AMINOTRANSFERASE (K071525) | Abbott Laboratories | 2008-03-19 |
| DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD (K073604) | Dade Behring, Inc. | 2008-03-13 |
| DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX (K073488) | Diazyme Laboratories | 2008-03-07 |
| LUMINEX LX 100/200 INSTRUMENT (K073506) | Luminex Corp. | 2008-03-07 |
| PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM (K073118) | Diagnostic Devices, Inc. | 2008-03-05 |
| ABX PENTRA URINE CAL (K071779) | Horiba Abx | 2008-03-05 |
| CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM (K073119) | Taidoc Technology Corporation | 2008-03-03 |
| MAJOR III BLOOD GLUCOSE MONITORING SYSTEM (K072274) | Bestgen Biotech Corp. | 2008-02-29 |
| VIDAS NT-PROBNP ASSAY, MODEL: 30 449 (K073091) | bioMerieux, Inc. | 2008-02-29 |
| ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL (K073191) | Thermofisher Scientific OY | 2008-02-28 |