| VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) (K990618) | Ventana Medical Systems, Inc. | 1999-07-23 |
| CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) (K990579) | Precision Biologic | 1999-07-23 |
| IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (K983203) | Diagnostic Products Corp. | 1999-07-12 |
| CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (K991605) | Abbott Laboratories | 1999-07-09 |
| EXCELL 22 (K991539) | Mwi, Inc. | 1999-07-01 |
| THERMAL ANGEL (K984640) | Estill Medical Technologies, Inc. | 1999-07-01 |
| CELL-DYN 1200 SYSTEM (K991142) | Abbott Laboratories | 1999-06-23 |
| DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 (K991402) | Dako Corp. | 1999-06-21 |
| PACIFIC HEMOSTASIS THROMBOSCREEN 200 (K991321) | Pacific Hemostasis | 1999-06-21 |
| HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) (K991362) | Morax | 1999-06-21 |
| MOUSE IGG1 NEGATIVE CONTROLS (K991454) | Dako Corp. | 1999-06-21 |
| SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE (K991876) | R&D Systems, Inc. | 1999-06-17 |
| VARIANT II B-THALASSEMIA (K991127) | Bio-Rad | 1999-06-10 |
| CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 (K990814) | Precision Biologic | 1999-06-07 |
| COAG-A-MATE MAX (K991101) | Organon Teknika Corp. | 1999-06-01 |
| GBACT + KIT (K984141) | Sienco, Inc. | 1999-05-28 |
| CRIT-SCAN II MONITOR (K983551) | In-Line Diagnostics Corp. | 1999-05-27 |
| TAS ANALYZER, MODEL 1009 (K990566) | Cardiovascular Diagnostics, Inc. | 1999-05-14 |
| COULTER Z2 ANALYZER (K991070) | Coulter Corp. | 1999-05-11 |
| DBEST OCCULT BLOOD TEST KIT (K984269) | Ameritek, Inc. | 1999-05-11 |
| ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K (K990957) | Astoria-Pacific, Inc. | 1999-05-11 |
| HEMOCHRON RESPONSE (K983475) | International Technidyne Corp. | 1999-05-03 |
| RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS (K990327) | Coulter Corp. | 1999-04-26 |
| LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 (K990858) | Bio-Rad | 1999-04-21 |
| HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE (K990449) | International Technidyne Corp. | 1999-04-13 |
| COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P (K983892) | Roche Diagnostics/Boehringer Mannheim GmbH | 1999-04-13 |
| TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA (K990172) | Coulter Corp. | 1999-04-13 |
| IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) (K990302) | Instrumentation Laboratory CO | 1999-04-08 |
| COULTER AC T DIFF 2 ANALYZER (K990352) | Coulter Corp. | 1999-04-01 |
| VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER (K990311) | Abx Diagnostics | 1999-03-31 |
| ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (K980737) | Nichols Institute Diagnostics | 1999-03-23 |
| AUTOMARQER (K990184) | Hamilton Thorne Research | 1999-03-19 |
| CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) (K990296) | Precision Biologic | 1999-03-18 |
| IMMUNO-TROL CONTROL CELLS (K984216) | Coulter Corp. | 1999-03-16 |
| GTI-PF4 ELISA (K983379) | Genetic Testing Institute | 1999-03-09 |
| PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA (K990046) | Pacific Hemostasis | 1999-02-17 |
| CBC-5D HEMATOLOGY CONTROL (K983032) | R&D Systems, Inc. | 1999-02-17 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (K983704) | Roche Diagnostic Systems, Inc. | 1999-02-10 |
| HEMOCHEK SAMPLE COLLECTION KIT (K984529) | Osborn Laboratories, Inc. | 1999-01-28 |
| CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (K982062) | Precision Biologicals, Inc. | 1999-01-13 |
| CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) (K981174) | Precision Biologicals, Inc. | 1999-01-13 |
| CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) (K981173) | Precision Biologicals, Inc. | 1999-01-13 |
| BIOCLOT APC SENSITIVITY (K983898) | Biopool Intl., Inc. | 1999-01-06 |
| REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT (K983914) | Corgenix, Inc. | 1998-12-22 |
| FERTILMARQ TEST KIT (K983473) | Embryotech Laboratories, Inc. | 1998-12-17 |
| VARIANT II HEMOGLOBIN A1C PROGRAM (K984268) | Bio-Rad | 1998-12-17 |
| SPIFE ALKALINE HEMOGLOBIN (K982426) | Helena Laboratories | 1998-12-17 |
| MAX-ACT (K983649) | Array Medical, Inc. | 1998-12-11 |
| QBC CENTRIFUGAL HEMATOLOGY CONTROL (K984099) | R&D Systems, Inc. | 1998-12-10 |
| COAGULATION CONTROL LEVEL 2 (ABNORMAL) (K984130) | Pacific Hemostasis | 1998-12-01 |
| COAGULATION CONTROL LEVEL 3 (ABNORMAL) (K984131) | Pacific Hemostasis | 1998-12-01 |
| COAGULATION CONTROL LEVEL 1 (NORMAL) (K984129) | Pacific Hemostasis | 1998-12-01 |
| ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT (K983172) | Diabetes Technologies, Inc. (Dti) | 1998-11-30 |
| GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (K983726) | Genzyme Corp. | 1998-11-25 |
| PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT (K983253) | Medisense, Inc. | 1998-11-20 |
| STAR AUTOMATED MULTI-PARAMETRIC ANALYZER (K983460) | American Bioproducts Co. | 1998-11-12 |
| CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 (K982167) | Coulter Corp. | 1998-11-09 |
| CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 (K982166) | Coulter Corp. | 1998-11-05 |
| MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700 (K983562) | Cdc Technologies, Inc. | 1998-11-03 |
| COAMATIC HEPARIN (K983178) | Instrumentation Laboratory CO | 1998-11-03 |
| SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (K981950) | Sysmex Corp. | 1998-11-03 |
| VFE (K983107) | Ramco Laboratories, Inc. | 1998-10-22 |
| TRACCELL 2000 SLIDE MAPPING SYSTEM (K982786) | Accumed Intl., Inc. | 1998-10-16 |
| ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 (K982209) | Sigma Diagnostics, Inc. | 1998-10-15 |
| COAGULATION FACTOR V DEFICIENT PLASMA (K981709) | Dade Behring, Inc. | 1998-10-13 |
| AVOCET PT (K980839) | Avocet Medical, Inc. | 1998-09-30 |
| HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT (K972866) | International Technidyne Corp. | 1998-09-30 |
| SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 (K981711) | Dade Behring, Inc. | 1998-09-30 |
| COAMATIC PLASMIN INHIBITOR (K981817) | Instrumentation Laboratory CO | 1998-09-28 |
| CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL (K982172) | Coulter Corp. | 1998-09-24 |
| BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982802) | Bayer Corp. | 1998-09-22 |
| HEMAPROMPT (K981661) | Aerscher Diagnostics | 1998-09-15 |
| HEMOSITE TEST SYSTEM (K973649) | Gds Technology, LLC | 1998-08-31 |
| IL TEST PLASMIN INHIBITOR (K981696) | Instrumentation Laboratory CO | 1998-08-27 |
| MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 (K981568) | Cdc Technologies, Inc. | 1998-08-21 |
| SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY (K980885) | Shield Diagnostics, Ltd. | 1998-08-21 |
| SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (K981761) | Sysmex Corp. | 1998-08-14 |
| GLYCACOR (K980888) | Exocell, Inc. | 1998-08-13 |
| MICRO21 WITH URINE SEDIMENT ANALYSIS (K982301) | Triangle Biomedical Sciences, Inc. | 1998-08-07 |
| HEPTRAC ELECTRONIC QUALITY CONTROL (K981815) | Medtronic Blood Management | 1998-07-30 |
| DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (K980635) | Dako Corp. | 1998-07-22 |
| DADE INNOVIN (K974343) | Dade Intl., Inc. | 1998-07-22 |
| STATUSFLOW (K982231) | R&D Systems, Inc. | 1998-07-20 |
| IL TEST PT-FIBRINOGEN RECOMBINANT (K981479) | Instrumentation Laboratory CO | 1998-07-07 |
| HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE (K974799) | International Technidyne Corp. | 1998-07-07 |
| ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY (K981342) | Abbott Laboratories | 1998-06-29 |
| AIC - CHEK (HBAIC-I) (K973365) | Express-Med, Inc. | 1998-06-15 |
| I-STAT COAGULATION CONTROL SET (K981752) | Biopool Intl., Inc. | 1998-06-15 |
| WINSCAN AUTOMATED IMAGING SYSTEM (K980375) | Applied Imaging Corp. | 1998-06-09 |
| DIASCREEN REAGENT STRIPS (K981555) | Chronimed, Inc. | 1998-06-01 |
| TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) (K981206) | Cardiovascular Diagnostics, Inc. | 1998-05-26 |
| IL TEST PLASMINOGEN (K981200) | Instrumentation Laboratory CO | 1998-05-26 |
| DIMERTEST LATEX ASSAY (K974596) | Agen Biomedical , Ltd. | 1998-05-26 |
| MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION (K980858) | Becton Dickinson Immunocytometry Systems | 1998-05-22 |
| ACCU-CHEK A1C HEMOGLOBIN TEST (K974491) | Boehringer Mannheim Corp. | 1998-05-13 |
| COLOSCREEN-ES (K980671) | Helena Laboratories | 1998-05-12 |
| STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (K981426) | Nova Biomedical Corp. | 1998-05-12 |
| STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (K981425) | Nova Biomedical Corp. | 1998-05-12 |
| STAT PROFILE M ANALYZER (K981427) | Nova Biomedical Corp. | 1998-05-12 |
| COAMATIC PLASMINOGEN (K974711) | Instrumentation Laboratory CO | 1998-05-01 |