| IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (K100031) | Ind Diagnostic, Inc. | 2010-07-19 |
| BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (K100817) | Princeton BioMeditech Corp. | 2010-07-01 |
| LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (K083878) | R2 Diagnostics, Inc. | 2010-06-25 |
| INRATIO/INRATIO2 TEST STRIPS (K092987) | Biosite Incorporated | 2010-06-11 |
| EASYCELL CELL LOCATOR (K092116) | Medica Corp. | 2010-05-12 |
| SPERMCHECK FERTILITY (K100341) | Princeton BioMeditech Corp. | 2010-05-04 |
| ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (K093129) | Illumina, Inc. | 2010-04-28 |
| ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING (K093974) | Osmetech Molecular Diagnostics | 2010-04-22 |
| BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C (K093394) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-04-08 |
| COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM (K093243) | Coagusense, Inc. | 2010-04-07 |
| SYSMEX MODEL XT-4000I (K091313) | Sysmex America, Inc. | 2010-03-30 |
| ROTEM DELTA THROMBOELASTOMETRY SYSTEM (K083842) | Pentapharm GmbH | 2010-03-23 |
| COAGUCHEK XS PRO SYSTEM (K093460) | Roche Diagnostics | 2010-03-18 |
| COAGUCHEK XS PLUS PST SYSTEM (K092940) | Roche Diagnostics Corp. | 2010-03-05 |
| CAPILLARYS NEONAT HB (PN 2006) (K091283) | Sebia | 2010-02-22 |
| HEMOSIL D-DIMER HS 500, CONTROLS (K090264) | Instrumentation Laboratory CO | 2010-02-05 |
| IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE (K093861) | Iris International, Inc. | 2010-02-05 |
| R & D SYSTEMS XERET HEMATOLOGY CONTROL (K100050) | R&D Systems, Inc. | 2010-01-29 |
| CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 (K082275) | Infopia Co, Ltd. | 2010-01-14 |
| OC-SENSOR DIANA IFOB TEST (K092330) | Polymedco Cancer Diagnostics, LLC | 2010-01-08 |
| STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (K093167) | Diagnostica Stago, Inc. | 2009-12-22 |
| STA LIATEST FREE PS (K092170) | Diagnostica Stago, Inc. | 2009-12-22 |
| STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER (K093001) | Diagnostica Stago, Incorporated | 2009-12-18 |
| S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 (K091711) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-12-11 |
| CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (K092868) | CellaVision AB | 2009-11-20 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K091916) | Siemens Healthcare Diagnostics | 2009-10-29 |
| VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA (K091284) | Affinity Biologicals, Inc. | 2009-10-28 |
| R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL (K091433) | R&D Systems, Inc. | 2009-10-28 |
| HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) (K090563) | Instrumentation Laboratory CO | 2009-10-09 |
| ACL TOP 700 LAS (K091980) | Instrumentation Laboratory CO | 2009-09-22 |
| XPERT HEMOSIL FACTOR II & FACTOR V ASSAY (K082118) | Cepheid | 2009-09-18 |
| THERMO SCIENTIFIC CYTO-CAL COUNT TUBES (K090810) | Microgenics Corp. | 2009-09-18 |
| URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS (K082811) | Urit Medical Electronic Co., Ltd. | 2009-09-11 |
| WIENER LAB. URINE STRIP 10 AND 11 (K083724) | Wiener Laboratorios Saic | 2009-09-02 |
| SCANSCOPE XT SYSTEM (K080564) | Aperio Technologies | 2009-08-14 |
| BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 (K090967) | Bd Biosciences | 2009-07-31 |
| VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 (K090699) | Bio-Rad Laboratories, Inc. | 2009-07-27 |
| DESTINY MAX COAGULATION ANALYZER (K083896) | Trinity Biotech | 2009-07-02 |
| MODIFICATION TO AVIE A1C TEST SYSTEM (K091400) | Mec Dynamics Corp | 2009-06-11 |
| STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (K090093) | Stanbio Laboratory | 2009-06-10 |
| HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (K090209) | Instrumentation Laboratory CO | 2009-06-02 |
| INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (K081769) | Siemens Healthcare Diagnostics | 2009-05-28 |
| A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC (K090413) | Bayer Healthcare, LLC | 2009-05-14 |
| MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 (K081286) | Dako North America, Inc. | 2009-05-08 |
| HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN (K083729) | Aniara Diagnostica, LLC | 2009-05-08 |
| PATHFAST D-DIMER (K072288) | Mitsubishi Kagaku Iatron | 2009-05-06 |
| CHEMPAQ XBC ANALYZER (K090013) | Chempaq A/S | 2009-04-21 |
| TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 (K082091) | Reametrix, Inc. | 2009-04-15 |
| UA-CELLULAR FOR IQ (K090201) | Streck | 2009-03-27 |
| THE BELMONT BUDDY LITE FLUID WARMER (K090508) | Belmont Instrument Corp. | 2009-03-26 |
| MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 (K082227) | Sebia | 2009-03-26 |
| AVIE A1C TEST SYSTEM (K081269) | Mec Dynamics Corp | 2009-03-20 |
| STAK-CHEX PLUS RETICS (K090137) | Streck | 2009-03-18 |
| ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS (K083518) | Instrumentation Laboratory CO | 2009-03-13 |
| CD4 COUNT (K083926) | Streck | 2009-02-11 |
| CELL-DYN EMERALD SYSTEM (K081495) | Abbott Laboratories | 2009-02-04 |
| PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (K080910) | Bioimagene, Inc. | 2009-02-04 |
| X-CAL (K083200) | Streck | 2009-02-03 |
| SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER (K083002) | Sysmex America, Inc. | 2009-02-03 |
| MEDONIC M SERIES (K083420) | Boule Medical AB | 2009-02-03 |
| COULTER BODY FLUID CONTROL (K082162) | Beckman Coulter, Inc. | 2009-02-03 |
| BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 (K083175) | Siemens Healthcare Diagnostics | 2009-01-26 |
| BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 (K083159) | Siemens Healthcare Diagnostics | 2009-01-26 |
| COULTER 6C CELL CONTROL, MODELS 628027 & A59925 (K081822) | Beckman Coulter, Inc. | 2009-01-21 |
| COULTER LIN-X LINEARITY CONTROL (K081641) | Beckman Coulter, Inc. | 2009-01-16 |
| ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS (K081895) | Siemens Medical Solutions Diagnostics | 2009-01-08 |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K081930) | Beckman Coulter, Inc. | 2008-12-19 |
| HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED (K082859) | Instrumentation Laboratory CO | 2008-12-19 |
| THROMBO TEK PSE, MODEL 90-480 (K082631) | R2 Diagnostics, Inc. | 2008-12-17 |
| STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER (K082248) | Diagnostica Stago, Inc. | 2008-12-12 |
| CELLAVISION DM96 WITH THE BODY FLUID APPLICATION (K080595) | CellaVision AB | 2008-12-05 |
| FACTOR VIII ANTIBODY SCREEN (K082205) | Genetic Testing Institute | 2008-11-20 |
| SCANSCOPE XT SYSTEM (K080254) | Aperio Technologies | 2008-10-31 |
| INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS (K081732) | Siemens Healthcare Diagnostics | 2008-10-24 |
| BINAXNOW G6PD TEST (K080003) | Binax, Inc. | 2008-10-23 |
| ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT (K073309) | Horiba Abx | 2008-10-17 |
| STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER (K082675) | Diagnostica Stago, Inc. | 2008-10-10 |
| SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER (K081890) | Sysmex America, Inc. | 2008-10-10 |
| G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 (K071132) | Tosoh Bioscience, Inc. | 2008-09-16 |
| SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER (K081610) | Sysmex America, Inc. | 2008-08-29 |
| FLOWCARE TLG REAGENT (K081526) | Beckman Coulter, Inc. | 2008-08-14 |
| BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 (K081213) | Bd Biosciences | 2008-08-14 |
| SCANSCOPE XT SYSTEM (K073677) | Aperio Technologies | 2008-08-01 |
| HEMOSIL D-DIMER (K073042) | Instrumentation Laboratory | 2008-07-31 |
| STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (K081719) | Stanbio Laboratory | 2008-07-18 |
| HEMOCCULT ICT (K080812) | Beckman Coulter, Inc. | 2008-06-25 |
| DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID (K080618) | Jas Diagnostics, Inc. | 2008-05-23 |
| ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (K073377) | Instrumentation Laboratory CO | 2008-05-04 |
| SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (K080887) | Sysmex America, Inc. | 2008-05-02 |
| VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH (K080911) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008-05-02 |
| RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA (K071867) | Paragondx, LLC | 2008-04-28 |
| TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM (K072714) | Roche Diagnostics Corp. | 2008-04-18 |
| AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS (K072686) | Axis-Shield Diagnostics, Ltd. | 2008-03-17 |
| DBEST ONE STEP OCCULT BLOOD TEST KITS (K071242) | Ameritek USA, Inc. | 2008-03-06 |
| DIMERTEST (K080069) | American Diagnostica, Inc. | 2008-02-13 |
| NRBC-CHEX FOR ADVIA (K080016) | Streck | 2008-02-05 |
| HANDHELD BASE UNIT (K072920) | Roche Diagnostics Corp. | 2008-01-31 |
| SPERMCHECK VASECTOMY (K073039) | Princeton BioMeditech Corp. | 2008-01-24 |
| POINTCARE NOW SYSTEM (K072869) | Pointcare Technologies, Inc. | 2008-01-14 |
| FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T (K073431) | Tianjin New Bay Bioresearch Co., Ltd. | 2008-01-14 |