| DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING (K020023) | Dako Corp. | 2002-02-28 |
| BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) (K013148) | Biogenex Laboratories | 2002-02-28 |
| A1CNOW FOR PROFESSIONAL USE (K020235) | Metrika, Inc. | 2002-02-15 |
| A1CNOW FOR RX HOME USE (K020234) | Metrika, Inc. | 2002-02-15 |
| STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 (K020138) | Gds Technology | 2002-02-11 |
| CARESIDE APTT (K014028) | Careside Hemotology, Inc. | 2002-02-08 |
| SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (K020109) | Sigma Diagnostics, Inc. | 2002-02-06 |
| R & D BODY FLUID CONTROL (K020229) | R&D Systems, Inc. | 2002-02-06 |
| HEMOCHRON JR. CITRATE APTT CUVETTE (K014008) | Itc, Inc. | 2002-01-24 |
| ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT (K013465) | Diabetes Technologies, Inc. | 2002-01-22 |
| R&D RET-LINE KIT (K013898) | R&D Systems, Inc. | 2002-01-22 |
| DADE THROMBOPLASTIN C PLUS (K013155) | Dade Behring, Inc. | 2002-01-18 |
| ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (K013078) | Helena Laboratories | 2002-01-10 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (K013549) | Sigma Diagnostics, Inc. | 2001-12-26 |
| IMMUNO-TROL LOW CELLS (K013842) | Beckman Coulter, Inc. | 2001-12-13 |
| REFERENCE CHECK, CATALOG NUMBER-RCN-10 (K013708) | Precision Biologic | 2001-12-10 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (K013545) | Sigma Diagnostics, Inc. | 2001-11-15 |
| DIMENSION HAIC ASSAY, MODEL DF105 (K011852) | Dade Behring, Inc. | 2001-11-15 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (K013544) | Sigma Diagnostics, Inc. | 2001-11-15 |
| BCS SYSTEM (K013114) | Dade Behring, Inc. | 2001-11-09 |
| SICKLE-CHEX (K013316) | Streck Laboratories, Inc. | 2001-11-06 |
| GLYCOSAL II HBA 1C TEST (K011933) | Provalis Diagnostics , Ltd. | 2001-11-02 |
| INFINITY HBA KIT, MODELS 537-A, 537-B (K012410) | Sigma Diagnostics, Inc. | 2001-10-26 |
| ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) (K011337) | Accumetrics, Inc. | 2001-10-16 |
| THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 (K012525) | Thermo Dma, Inc. | 2001-10-04 |
| PLATELETWORKS (K012723) | Helena Laboratories | 2001-09-28 |
| CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE (K012934) | Abbott Laboratories | 2001-09-28 |
| SYSMEX UF-50 (K012372) | Sysmex Corp. | 2001-09-28 |
| ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION (K012904) | Bayer Diagnostics Corp. | 2001-09-21 |
| SQA, SPERM QUALITY ANALYZER (K012352) | Medical Electronic Systems, LLC | 2001-09-21 |
| HEMOSIL RECOMBI PLASTIN (K012768) | Instrumentation Laboratory CO | 2001-09-18 |
| G7 AUTOMATED HPLC ANALYZER (K011434) | Tosoh Medics, Inc. | 2001-09-18 |
| LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 (K012722) | Bio-Rad | 2001-09-18 |
| ACTICLOT PROTEIN S, MODEL 843L (K012386) | American Diagnostica, Inc. | 2001-09-14 |
| BANDVIEW SYSTEM (K012103) | Applied Spectral Imaging , Ltd. | 2001-09-14 |
| PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 (K010750) | Fisher Diagnostics | 2001-09-07 |
| K-ASSAY D-DIMER CONTROLS (K012422) | Kamiya Biomedical Co. | 2001-08-21 |
| FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY (K011679) | Embryotech Laboratories, Inc. | 2001-08-15 |
| BCT SYSTEM (K011665) | Dade Behring, Inc. | 2001-08-09 |
| MODIFICATION TO THERMAL ANGEL (K012031) | Estill Medical Technologies, Inc. | 2001-07-26 |
| SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 (K011235) | Dade Behring, Inc. | 2001-07-20 |
| SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT (K010748) | Beckman Coulter, Inc. | 2001-07-10 |
| COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K011342) | Beckman Coulter, Inc. | 2001-07-09 |
| PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE (K010599) | International Technidyne Corp. | 2001-07-02 |
| PARA 5X (K011410) | Streck Laboratories, Inc. | 2001-06-26 |
| IL TEST PROS (K011424) | Instrumentation Laboratory CO | 2001-06-25 |
| DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP (K002885) | Dade Behring, Inc. | 2001-06-21 |
| HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) (K011389) | Canterbury Health Laboratories | 2001-06-21 |
| ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (K010455) | Diagnostica-Stago | 2001-06-07 |
| CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY (K010953) | Abbott Laboratories | 2001-06-06 |
| STA-LIATEST FREE PROTEIN S TEST KIT (K010963) | Diagnostica Stago, Inc. | 2001-06-06 |
| HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (K010193) | International Technidyne Corp. | 2001-06-06 |
| TINA-QUANT D-DIMER TEST SYSTEM (K011143) | Roche Diagnostics Corp. | 2001-05-29 |
| K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT (K002948) | Kamiya Biomedical Co. | 2001-05-18 |
| RUBICON PROTHROMBIN TIME MONITORING SYSTEM (K001699) | Lifescan, Inc. | 2001-05-15 |
| R & D 4K RETIC (K010470) | R&D Systems, Inc. | 2001-05-11 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K010494) | Dade Behring, Inc. | 2001-05-01 |
| COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 (K010765) | Beckman Coulter, Inc. | 2001-04-13 |
| IL TEST FREE PROTEIN S (K010379) | Instrumentation Laboratory CO | 2001-04-13 |
| STA -CALIBRATOR HBPM/LMWH KIT (K010350) | Diagnostica Stago, Inc. | 2001-04-09 |
| STA-QUALITY HBPM/LMWH KIT (K010324) | Diagnostica Stago, Inc. | 2001-04-09 |
| ADVIA RETIC PLUS (K010461) | R&D Systems, Inc. | 2001-04-03 |
| SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL (K010598) | Quantimetrix Corp. | 2001-03-23 |
| THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (K010158) | Sigma Diagnostics, Inc. | 2001-03-22 |
| ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI (K002706) | Roche Diagnostics Corp. | 2001-03-16 |
| CBC-SF (K010409) | R&D Systems, Inc. | 2001-03-16 |
| SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (K003267) | Sigma Diagnostics, Inc. | 2001-03-15 |
| DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER (K003301) | CellaVision AB | 2001-03-15 |
| SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (K003329) | Sigma Diagnostics, Inc. | 2001-03-01 |
| ACCUCLOT CONTROL I, MODEL A4089 (K003328) | Sigma Diagnostics, Inc. | 2001-03-01 |
| EASE-A-CULT (K002756) | Diagnostica, Inc. | 2001-02-23 |
| THROMBOREL S (K003870) | Dade Behring, Inc. | 2001-02-20 |
| ASSERACHROM HPIA TEST KIT (K003767) | Diagnostica Stago, Inc. | 2001-02-12 |
| 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 (K010064) | Beckman Coulter, Inc. | 2001-02-07 |
| 5C-ES CELL CONTROL, MODELS 7547191, 7547192 (K010066) | Beckman Coulter, Inc. | 2001-02-07 |
| ADVIA 120 HEMATOLOGY (K003796) | Bayer Corp. | 2001-02-05 |
| MINIQUANT D-DIMER, MODEL 1447 (K002642) | Biopool Intl., Inc. | 2001-02-05 |
| INSTACCULT (K002930) | Medtek Diagnostics, LLC | 2001-01-22 |
| CD-CAL PLUS CALIBRATOR (K003991) | R&D Systems, Inc. | 2001-01-16 |
| CBC-4K HEMATOLOGY CONTROL (K003874) | R&D Systems, Inc. | 2001-01-12 |
| !NSURE FECAL OCCULT BLOOD TEST (K002457) | Enterix, Inc. | 2001-01-12 |
| ABX PENTRA 60C+ HEMATOLOGY ANALYZER (K003677) | Abx Diagnostics | 2000-12-26 |
| VARIANT II TOTAL GHB (K003280) | Bio-Rad | 2000-12-19 |
| MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C (K003120) | Roche Diagnostics Corp. | 2000-12-18 |
| PENTRA 5D (K003534) | R&D Systems, Inc. | 2000-12-01 |
| LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (K003030) | Bio-Rad | 2000-11-29 |
| COLOSCREEN-ES (K003359) | Helena Laboratories | 2000-11-27 |
| BEHRING COAGULATION SYSTEM, MODEL BCS (K002080) | Dade Behring, Inc. | 2000-11-16 |
| R & D 3K RETIC (K003208) | R&D Systems, Inc. | 2000-11-07 |
| ABX MICROS CRP (K002646) | Abx Diagnostics | 2000-10-26 |
| COALIZA PROTEIN S-FREE (K002467) | Instrumentation Laboratory CO | 2000-10-13 |
| REFACTO LABORATORY STANDARD (K002350) | The Genetics Institute | 2000-10-05 |
| DRX HBA1C - FOR PRESCRIPTION HOME USE (K000885) | Metrika, Inc. | 2000-09-26 |
| PROTEIN C REAGENT (K002541) | Dade Behring, Inc. | 2000-09-26 |
| THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES (K002177) | Haemoscope Corp. | 2000-09-14 |
| FETALTROL (K002511) | Trillium Diagnostics, LLC | 2000-09-11 |
| COAGUCHEK S SYSTEM, MODEL 2138280 (K994349) | Roche Diagnostics Corp. | 2000-09-06 |
| SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION (K002528) | Sienco, Inc. | 2000-08-31 |
| MODIFICATION OF ACL ADVANCE (K002400) | Instrumentation Laboratory CO | 2000-08-30 |
| SLIDESCAN (K001420) | Applied Imaging Corp. | 2000-08-30 |