| SCANSCOPE XT SYSTEM (K071671) | Aperio Technologies | 2007-12-28 |
| HEMOSIL FIBRINOGEN-C (K073367) | Instrumentation Laboratory CO | 2007-12-27 |
| HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 (K073178) | R&D Systems, Inc. | 2007-12-27 |
| PF4 IGG (K071781) | Genetic Testing Institute | 2007-12-19 |
| D3 HEMATOLOGY ANALYZER, MODEL D3 (K071562) | Drew Scientific, Inc. | 2007-12-11 |
| SMARTCHECK INR SYSTEM (K071265) | Inverness Medical Innovations, Inc. | 2007-11-30 |
| PRIMUS A1CARE ASSAY (K062658) | Primus Corp. | 2007-11-26 |
| CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 (K072846) | R&D Systems, Inc. | 2007-11-26 |
| SYSMEX XE-5000 (K071967) | Sysmex America, Inc. | 2007-11-20 |
| HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S (K072268) | R&D Systems, Inc. | 2007-11-20 |
| INRATIO 2 PT MONITORING SYSTEM (K072727) | Hemosense, Inc. | 2007-10-26 |
| GENERAL SEMEN ANALYSIS KIT (K071737) | Dyn-Bioshaf (2006) , Ltd. | 2007-10-25 |
| HEMOCUE WBC SYSTEM (K071652) | Hemocue AB | 2007-10-25 |
| ACON UTI URINARY TRACT INFECTION TEST STRIPS (K063295) | ACON Laboratories, Inc. | 2007-10-12 |
| SCANSCOPE XT SYSTEM (K071128) | Aperio Technologies | 2007-10-10 |
| DCA VANTAGE, MODEL 5075 (K071466) | Siemens Medical Solutions Diagnostics | 2007-10-09 |
| SCANVIEW, MODEL SC-300 (K071398) | Applied Spectral Imaging , Ltd. | 2007-10-04 |
| CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 (K071681) | Beckman Coulter, Inc. | 2007-10-04 |
| FIBRINOGEN CALIBRATOR KIT (K072304) | Dade Behring, Inc. | 2007-09-19 |
| HEMOSIL D-DIMER HS (K070927) | Instrumentation Laboratory CO | 2007-09-17 |
| ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (K071255) | Hyphen Biomed | 2007-09-07 |
| CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 (K072096) | R&D Systems, Inc. | 2007-08-20 |
| SPECTROLYSE PAI-1, MODEL 101201 (K063323) | American Diagnostica, Inc. | 2007-08-15 |
| HEMOSIL RECOMBIPLASTIN 2G (K070005) | Instrumentation Laboratory CO | 2007-08-15 |
| I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 (K071319) | Bio-Rad, Diagnostics Grp. | 2007-06-26 |
| VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, (K070819) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2007-06-25 |
| INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST (K070660) | Alfa Scientific Designs, Inc. | 2007-06-21 |
| BC-3200 AUTO HEMATOLOGY ANALYZER (K063407) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-06-11 |
| OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL (K070453) | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-11 |
| BD TRITEST CD3/CD4/CD45, MODEL 340383 (K071143) | Bd Biosciences | 2007-06-06 |
| BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 (K071141) | Bd Biosciences | 2007-06-06 |
| ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 (K062025) | Corgenix, Inc. | 2007-05-29 |
| SYSMEX MODEL UF1000I (K070910) | Sysmex America, Inc. | 2007-05-25 |
| STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW (K060968) | Wortham Laboratories, Inc. | 2007-05-15 |
| FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST (K063693) | New Bay Bioresearch Co. , Ltd. | 2007-05-11 |
| COAGUCHEK XS PLUS SYSTEM (K071041) | Roche Diagnostics | 2007-05-11 |
| VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU (K070452) | Bio-Rad Laboratories, Inc. | 2007-05-07 |
| ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 (K063306) | Alfa Wassermann, Inc. | 2007-04-17 |
| MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON (K070734) | Diazyme Laboratories | 2007-04-09 |
| LYPHOCHEK DIABETES CONTROL (K070546) | Bio-Rad Laboratories | 2007-04-02 |
| HEMOSIL PROCLOT (K070635) | Instrumentation Laboratory CO | 2007-03-29 |
| R&D SICKLE QC CONTROL (K070334) | R&D Systems, Inc. | 2007-03-29 |
| QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS (K063864) | Medical Electronic Systems , Ltd. | 2007-03-26 |
| STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK (K063356) | Dade Behring, Inc. | 2007-03-23 |
| HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL (K063209) | Thermo Electron OY | 2007-03-21 |
| PLASMACON N, PLASMACON L-1, PLASMACON L-2 (K062306) | R2 Diagnostics, Inc. | 2007-03-16 |
| TINA-QUANT D-DIMER TEST SYSTEM (K062203) | Roche Diagnostics Corp. | 2007-03-14 |
| INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE (K063673) | Innovacon, Inc. | 2007-03-05 |
| TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS (K062840) | Biosite Incorporated | 2007-03-01 |
| HEMOSIL ANTITHROMBIN (K070301) | Instrumentation Laboratory CO | 2007-02-23 |
| PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (K061991) | Helena Laboratories | 2007-02-23 |
| RETIC-CHEX LINEARITY FOR BC (K070199) | Streck | 2007-02-23 |
| PATHIAM IMAGING SOFTWARE FOR HER2/NEU (K062756) | Bioimagene, Inc. | 2007-02-20 |
| INFINITI SYSTEM (K060564) | AutoGenomics, Inc. | 2007-02-07 |
| RAPIDTEG TEG-ACT TEST (K062604) | Haemoscope Corp. | 2007-01-31 |
| COAGUCHEK XS PT CONTROLS (K063823) | Roche Diagnostics Corp. | 2007-01-29 |
| COAGUCHEK XS SYSTEM (K062925) | Roche Diagnostics Corp. | 2007-01-29 |
| VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 (K062615) | Vision Biosystems, Inc. | 2007-01-29 |
| TRIAGE PROTEIN C TEST (K062530) | Biosite Incorporated | 2007-01-29 |
| DUET SYSTEM (K061602) | Bioview , Ltd. | 2007-01-23 |
| ACL TOP (K063679) | Instrumentation Laboratory CO | 2007-01-12 |
| VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (K061613) | Tripath Imaging | 2007-01-10 |
| IKONISCOPE ONCOFISH BLADDER TEST SYSTEM (K062755) | Ikonisys, Inc. | 2007-01-04 |
| MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM (K063643) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2006-12-27 |
| E-CHECK (XE) (K063218) | Streck | 2006-12-14 |
| STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (K061805) | Diagnostica Stago, Inc. | 2006-12-06 |
| VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 (K063400) | Bio-Rad Laboratories, Inc. | 2006-12-01 |
| BELMONT BUDDY PLUS FLUID WARMER (K062774) | Belmont Instrument Corp. | 2006-10-19 |
| ACCESS EPO ASSAY (K052223) | Beckman Coulter, Inc. | 2006-10-06 |
| COULTER LH 780 HEMATOLOGY ANALYZER (K061616) | Beckman Coulter, Inc. | 2006-10-04 |
| VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS (K062428) | Tripath Imaging, Inc. | 2006-09-29 |
| OCCULTECH FECAL OCCULT BLOOD RAPID TEST (K060953) | Yd Diagnostics Corp. | 2006-09-18 |
| BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 (K062087) | Bd Biosciences | 2006-09-14 |
| HEMOSIL LIQUID ANTITHROMBIN (K062431) | Instrumentation Laboratory CO | 2006-09-01 |
| HEMOSIL PROTEIN C (K062430) | Instrumentation Laboratory CO | 2006-09-01 |
| CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES (K060423) | Dakocytomation California, Inc. | 2006-08-15 |
| COAGUCHEK XS SYSTEM (K060978) | Roche Diagnostics | 2006-08-11 |
| IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM (K061392) | Ikonisys, Inc. | 2006-08-01 |
| STA - CONTROL LA 1+2 (K061803) | Diagnostica Stago, Inc. | 2006-07-28 |
| DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS (K060489) | Dade Behring, Inc. | 2006-07-21 |
| COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K061574) | Beckman Coulter, Inc. | 2006-07-21 |
| FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 (K061065) | Teco Diagnostics | 2006-07-14 |
| CELL-DYN RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |
| R&D CBC-3D + CRP HEMATOLOGY CONTROL (K061511) | R&D Systems, Inc. | 2006-07-10 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES (K061150) | Sysmex America, Inc. | 2006-07-06 |
| MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K053571) | Interlab S.R.L. | 2006-06-30 |
| NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) (K061360) | Lab Vision Corp. | 2006-06-27 |
| CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (K052291) | Sebia | 2006-06-27 |
| HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 (K061047) | Hemocue AB | 2006-06-08 |
| HEMA SCREEN SPECIFIC IFOBT (K060463) | Immunostics Inc., | 2006-06-06 |
| BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 (K060375) | Bd Biosciences | 2006-06-06 |
| R&D LH-NRBC HEMATOLOGY CONTROL (K061320) | R&D Systems, Inc. | 2006-06-02 |
| VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (K060227) | Vision Biosystems, Inc. | 2006-05-25 |
| BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (K050367) | Hyphen Biomed | 2006-05-24 |
| COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 (K061064) | Beckman Coulter, Inc. | 2006-05-17 |
| ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (K061014) | Helena Laboratories | 2006-05-10 |
| CRYOCHECK CLOT APCR (K060284) | Precision Biologic, Inc. | 2006-05-10 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES (K060656) | Sysmex America, Inc. | 2006-05-10 |
| INSURE II (K060930) | Enterix, Inc. | 2006-05-04 |
| STA-CEPHASCREEN KIT (K053111) | Diagnostica Stago, Inc. | 2006-05-04 |