| CARESIDE HEMOGLOBIN (K001462) | Careside, Inc. | 2000-08-21 |
| GLYCOSAL HBA1C TEST (K001392) | Provalis Diagnostics , Ltd. | 2000-08-21 |
| SYSMEX R-500 (K001683) | Sysmex Corporation of America | 2000-08-21 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K001645) | Dade Behring, Inc. | 2000-08-04 |
| DRX HBA1C (K000887) | Metrika, Inc. | 2000-07-26 |
| MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (K001891) | Bio/Data Corp. | 2000-07-12 |
| IL TEST LIQUID ANTITHROMBIN (K994238) | Instrumentation Laboratory CO | 2000-06-23 |
| BEHRING COAGULATION TIMER ANALYZER (BCT) (K001064) | Dade Behring, Inc. | 2000-06-21 |
| DADE BEHRING COAGULATION ANALYZER (BCT) (K001067) | Dade Behring, Inc. | 2000-06-20 |
| SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (K992799) | Sangui Biotech, Inc. | 2000-06-07 |
| MDA D-DIMER (K000492) | Organon Teknika Corp. | 2000-06-07 |
| BEHRING COAGULATION SYSTEM (BCS) (K000973) | Dade Behring, Inc. | 2000-05-26 |
| ABBOTT IMX GLYCATED HEMOGLOBIN II (K992085) | Abbott Laboratories | 2000-05-25 |
| CONTROL PLASMA N (K001256) | Dade Behring, Inc. | 2000-05-24 |
| NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY (K993131) | Primus, Inc. | 2000-05-22 |
| KAWASUMI LABORATORY BLOOD DRAWING KIT (K001043) | Kawasumi Laboratories America, Inc. | 2000-05-19 |
| STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER (K000611) | Bd Biosciences | 2000-05-18 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K001145) | Dade Behring, Inc. | 2000-05-11 |
| CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE (K000897) | Bd Biosciences | 2000-05-05 |
| THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES (K993678) | Haemoscope Corp. | 2000-05-05 |
| SERIM LEUKOCYTE ESTERASE TEST STRIPS (K000578) | Serim Research Corp. | 2000-05-05 |
| K-ASSAY AT-III (K000361) | Kamiya Biomedical Co. | 2000-04-26 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K000649) | Dade Behring, Inc. | 2000-04-25 |
| COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES (K993356) | Coulter Corp. | 2000-04-20 |
| PARA 12 PLUS RETICS (K000945) | Streck Laboratories, Inc. | 2000-04-18 |
| SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 (K000398) | Shield Diagnostics, Ltd. | 2000-04-17 |
| 939UDX URINE PATHOLOGY SYSTEM (K000373) | Intl. Remote Imaging Systems | 2000-04-14 |
| ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (K000528) | Sigma Diagnostics, Inc. | 2000-04-07 |
| ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (K000527) | Sigma Diagnostics, Inc. | 2000-04-07 |
| (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (K994194) | Cardiovascular Diagnostics, Inc. | 2000-03-28 |
| RETIC CHEX LINEARITY (K000115) | Streck Laboratories, Inc. | 2000-03-27 |
| THROMBOSTRATE CONTROL PLASMAS (K000679) | Pacific Hemostasis | 2000-03-24 |
| GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (K000239) | Genzyme Corp. | 2000-03-21 |
| ACL 9000 SYSTEM (K000053) | Instrumentation Laboratory CO | 2000-03-15 |
| FIBRINOGEN CALIBRATOR KIT (K994341) | Dade Behring, Inc. | 2000-03-03 |
| DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (K993957) | Dako Corp. | 2000-03-03 |
| CELL-CHEX (K000076) | Streck Laboratories, Inc. | 2000-03-03 |
| IMMUNOCYT (K994356) | Diagnocure, Inc. | 2000-02-23 |
| PACIFIC HEMOSTASIS THROMBOPLASTIN D (K994100) | Pacific Hemostasis | 2000-02-18 |
| GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (K993332) | Gradipore , Ltd. | 2000-02-16 |
| HMP CONTROLS (TAS) RAPIDPOINT (K994159) | Cardiovascular Diagnostics, Inc. | 2000-02-15 |
| I-STAT SYSTEM (K992571) | I-Stat Corp. | 2000-02-10 |
| AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) (K994006) | Avocet Medical, Inc. | 2000-02-03 |
| GTI-FVIII INHIBITOR ASSAY (K993553) | Genetic Testing Institute | 2000-02-01 |
| ADVANCED D-DIMER (K992957) | Dade Behring, Inc. | 2000-01-28 |
| XE CHECK (K994388) | Streck Laboratories, Inc. | 2000-01-14 |
| ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM (K992851) | Roche Diagnostics Corp. | 2000-01-14 |
| RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST (K993519) | Cardiovascular Diagnostics, Inc. | 2000-01-14 |
| HEMOSITE TEST SYSTEM (K994073) | Gds Technology, LLC | 2000-01-14 |
| BEHRING COAGULATION SYSTEM (BCS) (K992959) | Dade Behring, Inc. | 2000-01-11 |
| HEMOCHEK-A1C SAMPLE COLLECTION KIT (K990899) | Osborn Group, Inc. | 1999-12-21 |
| FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET (K993590) | Pointe Scientific, Inc., | 1999-12-21 |
| GRADILEIDEN V TEST (K992456) | Gradipore , Ltd. | 1999-12-21 |
| PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 (K994045) | Primus Corp. | 1999-12-21 |
| POLLER CALIBRANTS (K991439) | European Concerted Action on Anticoagulation | 1999-12-20 |
| ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM (K992531) | Accumetrics, Inc. | 1999-12-20 |
| CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (K993375) | Clinical Diagnostic Solutions, Inc. | 1999-12-20 |
| FRUCTOSAMINE, MODEL FR 106-01 (K991246) | A.P. Total Care, Inc. | 1999-12-16 |
| SIMPLIFY D-DIMER, MODEL DCGK1 (K993276) | Agen Biomedical , Ltd. | 1999-12-14 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K993299) | Dade Behring, Inc. | 1999-12-07 |
| COLON ALERT TEST (K992759) | Immunostics Inc., | 1999-12-06 |
| K-ASSAY FIBRINOGEN (K993482) | Kamiya Biomedical Co. | 1999-12-06 |
| SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (K992712) | Sigma Diagnostics, Inc. | 1999-12-06 |
| SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (K992711) | Sigma Diagnostics, Inc. | 1999-12-06 |
| STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR (K993104) | Nova Biomedical Corp. | 1999-12-02 |
| PLATELETWORKS (K990398) | Array Medical, Inc. | 1999-12-01 |
| RETIC-QUINOX (K993496) | Hematronix, Inc. | 1999-11-30 |
| PARA TECH PLUS RETICS (K993825) | Streck Laboratories, Inc. | 1999-11-30 |
| SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC (K991850) | Biosafe Laboratories, Inc. | 1999-11-26 |
| CD-CHEX CD 34 (K993126) | Streck Laboratories, Inc. | 1999-11-26 |
| STAK-CHEX PLUS RETICS (K992887) | Streck Laboratories, Inc. | 1999-11-22 |
| CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 (K992829) | Medical Analysis Systems, Inc. | 1999-11-22 |
| AVOCET ACUSURE SYSTEM (K991286) | Avocet Medical, Inc. | 1999-11-18 |
| PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II (K992921) | Primus Corp. | 1999-11-12 |
| R&D HGB/GLC WHOLE BLOOD CONTROL (K993321) | R&D Systems, Inc. | 1999-11-12 |
| SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER (K992875) | Sysmex Corp. | 1999-11-09 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K993174) | Dade Behring, Inc. | 1999-11-09 |
| PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM (K992492) | Roche Diagnostics Corp. | 1999-11-02 |
| IL TEST VON WILLEBRAND FACTOR (K992704) | Instrumentation Laboratory CO | 1999-11-01 |
| ABBOTT ARCHITECT GLYCATED HEMOGLOBIN (K991483) | Abbott Laboratories | 1999-11-01 |
| ABX PENTRA 60 HEMATOLOGY ANALYZER (K992511) | Abx Diagnostics | 1999-10-15 |
| INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC (K990992) | Roche Diagnostics Corp. | 1999-09-30 |
| MODIFICATION OF: CELL-DYN 1200 SYSTEM (K992444) | Abbott Laboratories | 1999-09-24 |
| QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (K992849) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999-09-23 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 (K992423) | Dade Behring, Inc. | 1999-09-21 |
| ACID HEMOGLOBIN KIT (K992199) | Helena Laboratories | 1999-09-21 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 (K992763) | Dade Behring, Inc. | 1999-09-21 |
| CALTAG FETAL HEMOGLOBIN TEST (K990641) | Caltag Laboratories, Inc. | 1999-09-17 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K992321) | Dade Behring, Inc. | 1999-09-17 |
| PRISMATHERM II, ASTOLINE (K991159) | Stihler Electronic GmbH | 1999-09-03 |
| PACIFIC HEMOSTASIS THROMBOSCREEN 400C (K992130) | Pacific Hemostasis | 1999-09-03 |
| ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (K991160) | Stihler Electronic GmbH | 1999-09-02 |
| HEPARIN CONTROL PLASMA LEVEL 2 (K992279) | Pacific Hemostasis | 1999-08-26 |
| HEPARIN CONTROL PLASMA LEVEL 1 (K992278) | Pacific Hemostasis | 1999-08-26 |
| VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) (K984567) | Ventana, Inc. | 1999-08-12 |
| ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER (K991839) | Abx Diagnostics | 1999-08-11 |
| CRYOCHECK LA SURE, MODEL SUR25-10 (K990580) | Precision Biologic | 1999-07-28 |
| DADE BEHRING BFTII (K984501) | Dade Behring, Inc. | 1999-07-28 |
| AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) (K984188) | Chroma Vision Medical Systems, Inc. | 1999-07-28 |
| CARESIDE PT (K991065) | Careside, Inc. | 1999-07-26 |