| DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT (K042193) | Diazyme Laboratories | 2004-10-29 |
| MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER (K042724) | Beckman Coulter, Inc. | 2004-10-29 |
| POLYMEDCO OC AUTO MICRO 80 FOB TEST (K041408) | Polymedco, Inc. | 2004-10-21 |
| CONTROL PLASMA N AND CONTROL PLASMA P (K042209) | Dade Behring, Inc. | 2004-10-21 |
| RETIC-CHEX FOR CELL-DYN (K042587) | Streck Laboratories, Inc. | 2004-10-19 |
| PURPLE/BLACK HEPARIN ASSAY CONTROL (K042206) | Medtronic Vascular | 2004-10-18 |
| HEPARINASE HR ACT CONTROL, MODEL 550-12 (K042175) | Medtronic Vascular | 2004-10-18 |
| LIQUI-HEME GLYCO A1C ASSAY (K031296) | Biodiagnostic Intl | 2004-10-15 |
| METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK (K042336) | Bio-Rad Laboratories, Inc. | 2004-10-14 |
| COULTER A T 5DIFF CAP PIERCE (CP) (K042173) | Beckman Coulter, Inc. | 2004-10-12 |
| VERIFYNOW-ASPIRIN ASSAY (K042423) | Accumetrics, Inc. | 2004-10-06 |
| HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (K042070) | Medtronic Vascular | 2004-10-01 |
| BD FACSCANTO WITH BD FACSANTO SOFTWARE (K041074) | Bd Biosciences | 2004-09-17 |
| BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (K042251) | Bayer Healthcare, LLC | 2004-09-17 |
| DUET SYSTEM (K040591) | Bioview , Ltd. | 2004-09-16 |
| BD FACSCANTO SYSTEM (K040725) | Becton Dickinson Immunocytometry Systems | 2004-09-10 |
| BD FACS 7-COLOR SETUP BEADS (K040026) | Becton Dickinson Immunocytometry Systems | 2004-09-10 |
| THE VITROS 5,1 FS CHEMISTRY SYSTEM (K041764) | Ortho-Clinical Diagnostics | 2004-09-09 |
| R&D CBC-XE HEMATOLOGY CONTROL (K042094) | R&D Systems, Inc. | 2004-09-01 |
| THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY (K041502) | Haemoscope Corp. | 2004-09-01 |
| ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS (K033491) | Roche Diagnostics Corp. | 2004-09-01 |
| URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS (K040703) | Dirui Industrial Co., Ltd. | 2004-08-26 |
| G5 I HBA1C TEST, G5 II HBA1C TEST (K041635) | Provalis Diagnostics , Ltd. | 2004-08-16 |
| POLYMEDCO OC LIGHT FOBT TEST (K041297) | Polymedco, Inc. | 2004-08-12 |
| HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST (K041202) | W.H.P.M., Inc. | 2004-08-12 |
| ADVANCED D-DIMER ASSAY (K041438) | Dade Behring, Inc. | 2004-08-11 |
| QWIKCHECK-BEADS (K041600) | Medical Electronics Systems , Ltd. | 2004-07-27 |
| FERTELL MALE FERTILITY TEST (K041039) | Genosis , Ltd. | 2004-07-20 |
| DIAPHARMA FACTOR X KIT (K040362) | Diapharma Group, Inc. | 2004-07-12 |
| LIQUICHEK HEMATOLOGY CONTROL (A) (K041457) | Bio-Rad | 2004-06-28 |
| CELLSEARCH EPITHELIAL CELL CONTROL KIT (K040898) | Veridex, LLC | 2004-06-28 |
| TRIAGE PROFILER S.O.B. PANEL (K040437) | Biosite Incorporated | 2004-06-25 |
| CRYOCHECK CLOT C (K040987) | Precision Biologic, Inc. | 2004-06-18 |
| HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM (K041234) | Hemocue, Inc. | 2004-06-10 |
| VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 (K040882) | bioMerieux, Inc. | 2004-06-10 |
| CDS HEMATOLOGY CALIBRATOR (CDS CAL) (K041130) | Clinical Diagnostic Solutions, Inc. | 2004-06-10 |
| BIO-RAD D-10 DUAL PROGRAM (K041444) | Bio-Rad Laboratories, Inc. | 2004-06-09 |
| SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED (K041240) | Fertility Solutions, Inc. | 2004-06-02 |
| HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (K040293) | Akers Laboratories, Inc. | 2004-05-28 |
| PHOSPHOPLASTIN RL (K040296) | R2 Diagnostics, Inc. | 2004-05-24 |
| INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K040146) | Interlab S.R.L. | 2004-05-04 |
| HEMOSIL VON WILLEBRAND ACTIVITY (K040843) | Instrumentation Laboratory CO | 2004-04-30 |
| VARIANT II HEMOGLOBIN A1C (K040872) | Bio-Rad Laboratories, Inc. | 2004-04-15 |
| REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 (K032139) | Corgenix, Inc. | 2004-04-05 |
| CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A (K032951) | Chrono-Log Corp. | 2004-04-02 |
| HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 (K040359) | Instrumentation Laboratory CO | 2004-03-19 |
| ARIOL (K033200) | Applied Imaging Corp. | 2004-03-18 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) (K040073) | Sysmex America, Inc. | 2004-03-18 |
| IMMUNICON CELLTRACKS AUTOPREP SYSTEM (K040077) | Immunicon Corp. | 2004-03-12 |
| LYPHOCHEK HEMOSTASIS CONTROL (K040275) | Bio-Rad | 2004-02-27 |
| HEMOSIL FACTOR VIII DEFICIENT PLASMA (K034007) | Instrumentation Laboratory CO | 2004-02-13 |
| SYSMEX POCH-100I (K032677) | Sysmex America, Inc. | 2004-02-11 |
| CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER (K033840) | CellaVision AB | 2004-02-10 |
| MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS (K033674) | Seradyn, Inc. | 2004-02-09 |
| QCA (VERSION 3.1) (K031363) | Cell Analysis, Inc. | 2004-02-05 |
| PHOSPHOLIN ES AND CALCIUM CHLORIDE (K033471) | R2 Diagnostics, Inc. | 2004-02-04 |
| INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K032862) | Interlab S.R.L. | 2004-02-03 |
| MEDONIC CA620/530 HEMATOLOGY ANALYZER (K032214) | Boule Medical AB | 2004-01-29 |
| ACL TOP MODEL, TOP (K033414) | Instrumentation Laboratory CO | 2004-01-12 |
| ARIOL HER-2/NEU IHC (K031715) | Applied Imaging Corp. | 2004-01-08 |
| HEMOSIL LIQUID ANTITHROMBIN XL (K033775) | Instrumentation Laboratory CO | 2004-01-02 |
| ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (K032113) | Chroma Vision Medical Systems, Inc. | 2003-12-23 |
| A1CNOW FOR HOME AND PROFESSIONAL USE (K033847) | Metrika, Inc. | 2003-12-23 |
| FACTOR II (PROTHROMBIN) G20210A KIT (K033612) | Roche Diagnostics Corp. | 2003-12-18 |
| FACTOR V LEIDEN KIT (DEN030005) | Roche Diagnostics Corp. | 2003-12-17 |
| MODIFICATION TO COATEST FACTOR VIII (K033631) | Instrumentation Laboratory CO | 2003-12-15 |
| AIACT KIT (K032952) | Sienco, Inc. | 2003-12-12 |
| POTENS + (K033137) | Wada, Inc. | 2003-12-08 |
| KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (K032827) | Tyco Healthcare | 2003-12-08 |
| ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER (K033548) | Roche Diagnostics Corp. | 2003-11-24 |
| IMMUNICON CELLTRACKS ANALYZER (K030263) | Immunicon Corp. | 2003-11-24 |
| HBA SPERM-HYALURONAN BINDING ASSAY (K032874) | Biocoat, Inc. | 2003-11-24 |
| OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) (K031380) | Olympus America, Inc. | 2003-11-14 |
| ATAC HEMOGLOBIN A1C REAGENT KIT (K031042) | Clinical Data, Inc. | 2003-11-03 |
| CRYOCHECK WEAK LUPUS POSITIVE CONTROL (K032804) | Precision Biologic | 2003-11-03 |
| GLYCOHEMOSURE HBA1C CONTROL (K032791) | Quantimetrix Corp. | 2003-10-30 |
| QUANTEX D-DIMER (K032419) | Instrumentation Laboratory CO | 2003-10-24 |
| STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (K032482) | Stanbio Laboratory | 2003-10-24 |
| COULTER LH 750 HEMATOLOGY ANALYZER (K032342) | Beckman Coulter, Inc. | 2003-09-26 |
| EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM (K031898) | Ekf Diagnostic GmbH | 2003-09-24 |
| HEMAPROMPT GASTRIC (K031356) | Aerscher Diagnostics | 2003-09-24 |
| GLYCOMARK (K031604) | Tomen America, Inc. | 2003-09-22 |
| LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 (K032611) | Bio-Rad | 2003-09-17 |
| IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K032039) | Sysmex America, Inc. | 2003-09-08 |
| SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 (K031377) | Dade Behring, Inc. | 2003-09-08 |
| I-STAT KAOLIN ACT TEST (K023582) | I-Stat Corporation | 2003-09-08 |
| ADVIA 60 HEMATOLOGY ANALYZER (K032524) | Bayer Healthcare, LLC | 2003-09-08 |
| VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 (K030328) | bioMerieux, Inc. | 2003-09-02 |
| ARKIT HBA1C (K030553) | Arkray, Inc. | 2003-09-02 |
| D-10 HEMOGLOBIN A1C (K031043) | Bio-Rad Laboratories, Inc. | 2003-08-27 |
| HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 (K032203) | Hemocue, Inc. | 2003-08-25 |
| DUET SYSTEM (K030192) | Bioview , Ltd. | 2003-08-20 |
| COULTER LH 500 HEMATOLOGY ANALYZER (K032000) | Beckman Coulter, Inc. | 2003-08-13 |
| LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 (K032017) | Bio-Rad | 2003-08-08 |
| HEMOGLOBIN A1C REAGENT SET (K031539) | Pointe Scientific, Inc., | 2003-08-06 |
| HEMOSIL FACTOR IX DEFICIENT PLASMA (K031829) | Instrumentation Laboratory CO | 2003-07-31 |
| COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER (K032013) | Beckman Coulter, Inc. | 2003-07-24 |
| GENERAL SEMEN ANALYSIS (GSA) KIT (K024337) | Bioshaf , Ltd. | 2003-07-03 |
| MICROHEATER (K031478) | Belmont Instrument Corp. | 2003-07-02 |
| K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C (K030687) | Kamiya Biomedical Co. | 2003-06-27 |