| QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) (K023335) | Qc Sciences, LLC | 2003-06-18 |
| CONTROL PLASMA LMW HEPARIN (K030965) | Instrumentation Laboratory CO | 2003-06-06 |
| COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING (K030845) | Roche Diagnostics Corp. | 2003-05-22 |
| TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) (K030828) | Beckman Coulter, Inc. | 2003-05-21 |
| HEMOSIL FACTOR X DEFICIENT PLASMA (K031122) | Instrumentation Laboratory CO | 2003-05-19 |
| CELL-DYN 1800 SYSTEM (K030513) | Abbott Laboratories | 2003-05-12 |
| GLYCA-DIRECT FRUCTOSAMINE (K023654) | Polymedco, Inc. | 2003-05-02 |
| CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (K023991) | Precision Biologic | 2003-04-28 |
| COULTER LH 750 BODY FLUIDS APPLICATION (K030606) | Beckman Coulter, Inc. | 2003-04-21 |
| COULTER ACT 5DIFF AUTOLOADER (AL) (K030291) | Beckman Coulter, Inc. | 2003-04-17 |
| MICROS 60 (K030799) | Abx Diagnostics | 2003-04-08 |
| HEMOCHRON RESPONSE/SYSTEM (K030818) | International Technidyne Corp. | 2003-04-02 |
| COLONCARE (K030216) | Care Products, Inc. | 2003-04-02 |
| MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM (K030740) | Roche Diagnostics Corp. | 2003-04-01 |
| G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (K024006) | Pointe Scientific, Inc., | 2003-03-31 |
| CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 (K023990) | Precision Biologic | 2003-03-19 |
| HEMOSIL FACTOR XI DEFICIENT PLASMA (K030287) | Instrumentation Laboratory CO | 2003-03-19 |
| URS-1B (BLOOD TEST) (K023297) | Teco Diagnostics | 2003-03-06 |
| CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A (K030408) | Beckman Coulter, Inc. | 2003-03-04 |
| LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 (K030182) | Bio-Rad | 2003-02-24 |
| PLATELETWORKS, MODELS PW-A, PW-C (K023761) | Helena Laboratories | 2003-02-14 |
| HEMOSIL FACTOR VII DEFICIENT PLASMA (K024082) | Instrumentation Laboratory CO | 2003-02-12 |
| MODIFICATION TO PENTRA 60 AND PENTRA 60C+ (K030144) | Abx Diagnostics | 2003-01-31 |
| ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM (K023561) | International Technidyne Corp. | 2003-01-31 |
| STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D (K022976) | Dade Behring, Inc. | 2003-01-16 |
| MODIFICATION TO STANDARD HUMAN PLASMA (K023141) | Dade Behring, Inc. | 2003-01-16 |
| CDS 3-PD HEMATOLOGY CONTROLS (K024173) | Clinical Diagnostic Solutions, Inc. | 2003-01-14 |
| HEMOSIL FACTOR V DEFICIENT PLASMA (K023839) | Instrumentation Laboratory CO | 2003-01-14 |
| RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS (K023763) | Randox Laboratories, Ltd. | 2003-01-13 |
| PENTRA 80 (K024002) | Abx Diagnostics | 2003-01-03 |
| SICKLE-CHEX SOLUBILITY KIT (K023656) | Streck Laboratories, Inc. | 2002-12-30 |
| A1CNOW FOR HOME USE (K022661) | Metrika, Inc. | 2002-12-13 |
| FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN (K023362) | Fisher Diagnostics | 2002-12-09 |
| SST SALIVA SUPPORTING TABLETS (K023046) | Sinclair Pharmaceuticals, Ltd. | 2002-12-02 |
| STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C (K022977) | Dade Behring, Inc. | 2002-11-27 |
| RANDOX HAEMOGLOBIN A1C (K021897) | Randox Laboratories, Ltd. | 2002-11-26 |
| VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (K022021) | Vital Scientific N.V. | 2002-11-01 |
| CONTROL PLASMA N (K023309) | Dade Behring, Inc. | 2002-11-01 |
| CONTROL PLASMA P (K023312) | Dade Behring, Inc. | 2002-11-01 |
| FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (K021976) | Vital Scientific N.V. | 2002-10-25 |
| PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 (K021190) | Roche Diagnostics Corp. | 2002-10-25 |
| INRATIO SELF-TEST (K021923) | Hemosense, Inc. | 2002-10-24 |
| PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 (K020831) | Roche Diagnostics Corp. | 2002-10-24 |
| IQ 200 SYSTEM (K022774) | Intl. Remote Imaging Systems | 2002-10-21 |
| ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD (K022668) | Bayer Diagnostics Corp. | 2002-10-15 |
| LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL (K023032) | Bioresource Technology, Inc. | 2002-10-08 |
| VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 (K020810) | bioMerieux, Inc. | 2002-10-03 |
| HARMONY INR MONITORING SYSTEM (K022922) | Lifescan, Inc. | 2002-09-30 |
| MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (K012138) | Chroma Vision Medical Systems, Inc. | 2002-09-30 |
| CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (K022512) | Immunicon Corp. | 2002-09-30 |
| LIFEGUARD (K022755) | Medtek, LLC | 2002-09-24 |
| ADVIA TESTPOINT CSF CONTROL (K022968) | Bayer Diagnostics Corp. | 2002-09-24 |
| SQA V, SPERM QUALITY ANALYZER (K021746) | Medical Electronic Systems, LLC | 2002-09-20 |
| ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (K022331) | Bayer Diagnostics Corp. | 2002-09-11 |
| IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ (K022528) | Iq Corp. | 2002-09-11 |
| AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED (K021162) | Sigma Diagnostics, Inc. | 2002-08-30 |
| COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550) | Instrumentation Laboratory CO | 2002-08-27 |
| PROTEIN S AC (K022290) | Dade Behring, Inc. | 2002-08-27 |
| ENOXAPARIN TEST CARD (K013305) | Cardiovascular Diagnostics, Inc. | 2002-08-23 |
| BIOTEST HEMOGLOBIN MEASURING SYSTEM (K020710) | Biotest Medizintechnik GmbH | 2002-08-14 |
| COAMATIC AT-400 (K022195) | Instrumentation Laboratory CO | 2002-08-07 |
| MDA D-DIMER (K021877) | bioMerieux, Inc. | 2002-08-07 |
| PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 (K022200) | Abx Diagnostics | 2002-07-29 |
| MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K022161) | Beckman Coulter, Inc. | 2002-07-29 |
| VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL (K022046) | Vital Scientific N.V. | 2002-07-23 |
| BAYER RAPIDPOINT 405 SYSTEM (K020616) | Bayer Diagnostics Corp. | 2002-07-17 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 (K020979) | Dade Behring, Inc. | 2002-06-27 |
| SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I (K021241) | Sysmex Corporation of America | 2002-06-25 |
| MODIFICATION TO PARA 5X (K021922) | Streck Laboratories, Inc. | 2002-06-25 |
| MEDICA EASYQC HEMATOCRIT CONTROL (K021924) | Bionostics, Inc. | 2002-06-24 |
| INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST (K021423) | Alfa Scientific Designs, Inc. | 2002-06-17 |
| HEMOGLOBIN A1C CONTROL (K021484) | Canterbury Scientific , Ltd. | 2002-06-14 |
| DEROYAL SURGICAL, UMBILICUP (K020753) | Deroyal | 2002-06-13 |
| ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) (K012701) | Accumetrics, Inc. | 2002-06-12 |
| COULTER CELLPREP (K021150) | Beckman Coulter, Inc. | 2002-06-11 |
| ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (K020914) | Helena Laboratories | 2002-05-23 |
| MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) (K013596) | Accumetrics, Inc. | 2002-05-16 |
| HEMOSIL HIGH ABNORMAL CONTROL ASSAYED (K021024) | Instrumentation Laboratory CO | 2002-05-16 |
| VITAL SCIENTIFIC PT WITH CALCIUM (K020840) | Vital Scientific N.V. | 2002-05-15 |
| G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (K020489) | Tosoh Medics, Inc. | 2002-05-14 |
| HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) (K021023) | Instrumentation Laboratory CO | 2002-05-14 |
| AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL (K020618) | Aalto Scientific, Ltd. | 2002-05-14 |
| I-STAT PROTHROMBIN TIME TEST (K020355) | I-Stat Corporation | 2002-05-14 |
| HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) (K021022) | Instrumentation Laboratory CO | 2002-05-14 |
| INRATIO (K020679) | Hemosense, Inc. | 2002-05-06 |
| POLYMEDCO HBA1C TEST (K020532) | Polymedco, Inc. | 2002-04-24 |
| ACTICHROME HEPARIN (ANTI-FIIA) (K013637) | American Diagnostica, Inc. | 2002-04-16 |
| LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (K020878) | Bio-Rad | 2002-04-15 |
| HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY (K020496) | Sysmex Corporation of America | 2002-04-12 |
| CAL-CHEX CD PLUS (K020469) | Streck Laboratories, Inc. | 2002-04-04 |
| IMMUNE CELL FUNCTION ASSAY (K013169) | Cylex, Inc. | 2002-04-02 |
| HEMOCHRON JR. SIGNATURE + (K020798) | International Technidyne Corp. | 2002-03-28 |
| AUTODIMER ASSAY MODEL # 1431 (K012755) | Xtrana, Inc. | 2002-03-15 |
| IMUBIND TPA ELISA, MODEL 860 (K013492) | American Diagnostica, Inc. | 2002-03-13 |
| AUTOMARQER (K012805) | Hamilton Thorne Research | 2002-03-13 |
| ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (K013318) | American Diagnostica, Inc. | 2002-03-08 |
| BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (K012960) | Biogenex Laboratories | 2002-03-08 |
| IMUBIND PLASMA PAI-1 ELISA,MODEL 822 (K013168) | American Diagnostica, Inc. | 2002-03-07 |
| ASTOFLO (K020060) | Nats Corp. | 2002-03-05 |
| ABX MICROS 60 HEMATOLOGY ANALYZER (K014203) | Abx Diagnostics | 2002-02-28 |