| HEMOSIL PT-FIBRINOGEN HS PLUS (K060931) | Instrumentation Laboratory CO | 2006-05-02 |
| NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) (K060462) | Lab Vision Corp. | 2006-04-24 |
| GUAVA EZCD4 SYSTEM (K053497) | Guava Technologies, Inc. | 2006-04-14 |
| HEMOSIL SYNTHASIL (K060688) | Instrumentation Laboratory CO | 2006-04-13 |
| VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 (K053520) | Tripath Imaging, Inc. | 2006-04-11 |
| VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 (K060650) | Ortho-Clinical Diagnostics, Inc. | 2006-04-06 |
| COULTER 5C CELL CONTROL (K060464) | Beckman Coulter, Inc. | 2006-03-28 |
| IMMOCARE (K052598) | Care Diagnostic, Inc. | 2006-03-16 |
| RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 (K050709) | Wallac OY | 2006-03-08 |
| ACL ELITE; ACL ELITE PRO (K060162) | Instrumentation Laboratory CO | 2006-02-21 |
| NRBC-CHEX FOR LH (K060083) | Streck | 2006-02-09 |
| DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS (K053411) | Microgenics Corp. | 2006-02-03 |
| IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM (K052577) | Ikonisys, Inc. | 2006-01-24 |
| D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM (K060001) | Bio-Rad Laboratories, Inc. | 2006-01-20 |
| PF4 ENHANCED SOLID PHASE ELISA (K053559) | Genetic Testing Institute | 2006-01-20 |
| VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG (K052825) | Affinity Biologicals, Inc. | 2006-01-20 |
| CELL-CHEX AUTO (K053362) | Streck | 2006-01-13 |
| HEMOSIL PROS (K053499) | Instrumentation Laboratory CO | 2006-01-13 |
| SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER (K053135) | Sysmex America, Inc. | 2006-01-04 |
| HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL (K052697) | Akers Biosciences, Inc. | 2006-01-04 |
| ABX MICROS CRP 200, OPTION IM (K053308) | Horiba Abx | 2005-12-29 |
| BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 (K050365) | Hyphen Biomed | 2005-12-27 |
| COAG-A-MATE MTX III (K051030) | bioMerieux, Inc. | 2005-12-23 |
| BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR (K051472) | Hyphen Biomed | 2005-12-23 |
| CHEMPAQ XBC ANALYZER (K050758) | Chempaq A/S | 2005-12-22 |
| T-TEK (K050817) | R2 Diagnostics, Inc. | 2005-12-12 |
| EXTENDSURE HBFASC CONTROL (K053031) | Cantebury Scientific , Ltd. | 2005-12-07 |
| MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (K051693) | Bayer Healthcare, LLC | 2005-12-07 |
| MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER (K052905) | Beckman Coulter, Inc. | 2005-11-18 |
| LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (K052838) | Bio-Rad | 2005-11-09 |
| BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 (K043007) | Hyphen Biomed | 2005-11-07 |
| ACTICLOT, MODEL 824 (K052124) | American Diagnostica, Inc. | 2005-10-17 |
| CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (K050265) | Chrono-Log Corp. | 2005-10-14 |
| BELMONT BUDDY FLUID WARMER (K052547) | Belmont Instrument Corp. | 2005-10-13 |
| CARE FECAL OCCULT BLOOD TEST, MODEL KT313 (K051806) | Epitope Diagnostics, Inc. | 2005-10-03 |
| TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST (K052464) | Roche Diagnostics Corp. | 2005-09-30 |
| SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER (K051459) | Sysmex America, Inc. | 2005-09-23 |
| CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 (K050448) | Horiba Abx | 2005-09-23 |
| MS 4/5 HEMATOLOGY ANALYZER (K050421) | Melet Schloesing Laboratories USA | 2005-08-31 |
| C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (K052101) | Roche Diagnostics | 2005-08-26 |
| IQ BODY FLUIDS CONTROL (K051706) | Streck | 2005-08-17 |
| STRATUS CS D-DIMER (K051597) | Dade Behring, Inc. | 2005-08-17 |
| MODIFICATION TO DUET SYSTEM (K050840) | Bioview , Ltd. | 2005-08-16 |
| CD-CHEX PLUS BC (K051633) | Streck | 2005-08-16 |
| COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (K050821) | Zycare | 2005-08-16 |
| VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (K051282) | Tripath Imaging, Inc. | 2005-08-16 |
| SLIVASURE (K051409) | Scandinavian Formulas, Inc. | 2005-08-08 |
| HEMOGLOBIN A1C REAGENT SET (K051200) | Teco Diagnostics | 2005-08-08 |
| IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K051199) | Sysmex America, Inc. | 2005-08-08 |
| VERIFYNOW-P2Y12 ASSAY (K051231) | Accumetrics, Inc. | 2005-08-05 |
| ITAG MHC TETRAMER CMV ASSAY (K051122) | Beckman Coulter, Inc. | 2005-08-01 |
| MS 9/5 HEMATOLOGY ANALYZER (K050436) | Melet Schloesing Laboratories USA | 2005-07-27 |
| AFINION HBALC (K050574) | Axis-Shield Poc AS | 2005-07-22 |
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |
| R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL (K051339) | R&D Systems, Inc. | 2005-07-12 |
| HEMORAM/AGGRAM ANALYZER (K050053) | Helena Laboratories | 2005-07-11 |
| DADE THROMBIN REAGENT (K050928) | Dade Behring, Inc. | 2005-06-29 |
| TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS (K050799) | Biosite Incorporated | 2005-06-29 |
| VISULIZE FACTOR IX ANTIGEN KIT (K051054) | Affinity Biologicals, Inc. | 2005-06-29 |
| HBA1C ENZYMATIC ASSAY (K050178) | General Atomics | 2005-06-28 |
| FISHVIEW (K050236) | Applied Spectral Imaging , Ltd. | 2005-06-27 |
| INVIEW (K051321) | Metrika, Inc. | 2005-06-13 |
| IMMEDIA PROTHROMBIN TIME SYSTEM (K050243) | Farallon Medial, Inc. | 2005-06-06 |
| ABX ERYTROL (K050721) | Horiba Abx | 2005-06-01 |
| HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K051040) | Medtronic Perfusion Systems | 2005-05-24 |
| BIO-RAD VARIANT NBS SICKLE CELL PROGRAM (K051072) | Bio-Rad Laboratories, Inc. | 2005-05-12 |
| VENTANA IMAGE ANALYSIS SYSTEM (K050012) | Tripath Imaging, Inc. | 2005-05-06 |
| HEMONIR TM (K050014) | Nir Diagnostics, Inc. | 2005-05-05 |
| RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K050589) | Sysmex America, Inc. | 2005-05-04 |
| HEMOSIL FACTOR II DEFICIENT PLASMA (K050661) | Instrumentation Laboratory CO | 2005-05-02 |
| HEMOSIL D-DIMER HS (K050544) | Instrumentation Laboratory CO | 2005-04-26 |
| ABX PENTRA DX 120: OPTION SPS EVOLUTION (K050719) | Horiba Abx | 2005-04-26 |
| MDA B.30 (K050513) | bioMerieux, Inc. | 2005-04-01 |
| HEMOSIL SILICA CLOTTING TIME (K050221) | Instrumentation Laboratory CO | 2005-03-30 |
| IQ 200 URINE ANALYZER BODY FLUIDS MODULE (K050235) | Iris International, Inc. | 2005-03-23 |
| CRYOCHECK CLOT S (K043571) | Precision Biologic, Inc. | 2005-03-18 |
| BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR (K043451) | Hyphen Biomed | 2005-03-17 |
| HEMOSIL D-DIMER (K050278) | Instrumentation Laboratory CO | 2005-03-10 |
| DAKOCYTOMATION ER/PR PHARMDX KIT (K042884) | Dakocytomation California, Inc. | 2005-02-15 |
| COULTER LH 750 HEMATOLOGY ANALYZER (K050057) | Beckman Coulter, Inc. | 2005-02-10 |
| HEMOCHRON SIGNATURE ELITE (K050016) | International Technidyne Corp. | 2005-02-10 |
| PROSTATE-63 CANCER DIAGNOSTIC TEST (K050063) | Asymmetrx | 2005-02-09 |
| HEMOSIL FACTOR XII DEFICIENT PLASMA (K043459) | Instrumentation Laboratory CO | 2005-02-09 |
| FLOWCARE PLG CD4 REAGENT (K043215) | Beckman Coulter, Inc. | 2005-01-19 |
| HEMOSIL RECOMBIPLASTIN (K043184) | Instrumentation Laboratory CO | 2004-12-22 |
| PEFAKIT APC-R FACTOR V LEIDEN (K042762) | Pentapharm , Ltd. | 2004-12-22 |
| PEFAKIT APC-R FACTOR V LEIDEN CONTROLS (K042760) | Pentapharm , Ltd. | 2004-12-22 |
| ANEMIAPRO SELF-SCREENER (K042379) | Biosafe Laboratories, Inc. | 2004-12-15 |
| ENZYGNOST F+2 (MONOCLONAL) TEST KIT (K042687) | Dade Behring, Inc. | 2004-12-10 |
| TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 (K042723) | Biosite Incorporated | 2004-12-07 |
| HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K043080) | Medtronic Vascular | 2004-12-03 |
| COATEST SP FVIII (K042576) | Instrumentation Laboratory CO | 2004-12-02 |
| DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS (K042941) | Dade Behring, Inc. | 2004-12-02 |
| CONTROL PLASMA N, PROC CONTROL PLASMA (K042333) | Dade Behring, Inc. | 2004-12-01 |
| FIBROTEK FIB (K042919) | R2 Diagnostics, Inc. | 2004-11-29 |
| TRIAGE D-DIMER TEST, MODEL 98100 (K042890) | Biosite Incorporated | 2004-11-29 |
| FLOWCARE SYSTEM (K041882) | Pointcare Technologies, Inc. | 2004-11-23 |
| SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT (K042459) | Beckman Coulter, Inc. | 2004-11-17 |
| LIQUICHEK RETICULOCYTE CONTROL (A) (K042836) | Bio-Rad | 2004-11-05 |
| QC-BEADS (K042750) | Bioscreen, Inc. | 2004-10-29 |