| BAYER LIGAND PLUS 1, 2, 3 CONTROLS (K030452) | Bayer Diagnostics Corp. | 2003-03-03 |
| PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS (K024182) | Precision Systems, Inc. | 2003-03-03 |
| ASCENSIA BREEZE BLOOD GLUCOSE METER (K024062) | Bayer Corp. | 2003-03-03 |
| FIRST RESPONSE PREGNANCY TEST (K030258) | Armkel, LLC | 2003-02-25 |
| WAKO L-TYPE GLUCOSE 2 (K024281) | Wako Chemicals USA, Inc. | 2003-02-24 |
| TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL (K030286) | Biosite Incorporated | 2003-02-21 |
| MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS (K024193) | Ortho-Clinical Diagnostics | 2003-02-21 |
| ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR (K023407) | Elan Diagnostics | 2003-02-14 |
| ALBUMIN COBALT BINDING TEST (ACB TEST) (K023824) | Ischemia Technologies, Inc. | 2003-02-14 |
| WIENER LAB. BILIRUBINA DIRECT AA (K024116) | Wiener Laboratories Saic | 2003-02-12 |
| WAKO NEFA LINEARITY SET (K030065) | Wako Chemicals USA, Inc. | 2003-02-11 |
| BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (K023944) | Bayer Corp. | 2003-02-11 |
| ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS (K024194) | Lifescan, Inc. | 2003-02-07 |
| CALIBRATION PACK, MODELS A9100-101S AND A9100-103S (K023792) | Thermo Orion | 2003-01-31 |
| SETPOINT CHEMISTRY CALIBRATOR (K030169) | Bayer Healthcare, LLC | 2003-01-31 |
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764) | Beckman Coulter, Inc. | 2003-01-28 |
| LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS (K030150) | Cliniqa Corporation | 2003-01-28 |
| VACUETTE TRACE ELEMENTS TUBES (K023971) | Greiner Bio-One Vacuette North America | 2003-01-27 |
| PICCOLO TRIGLYCERIDES TEST SYSTEM (K023639) | Abaxis, Inc. | 2003-01-24 |
| ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (K030102) | Bayer Healthcare, LLC | 2003-01-24 |
| PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (K023642) | Abaxis, Inc. | 2003-01-24 |
| PICCOLO HDL TEST SYSTEM (K023640) | Abaxis, Inc. | 2003-01-24 |
| ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (K024234) | Bayer Corp. | 2003-01-23 |
| TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS (K030089) | Biosite Incorporated | 2003-01-23 |
| LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS (K030074) | Cliniqa Corporation | 2003-01-21 |
| GLUCOSE-SL-C ASSAY, MODEL 257-30 (K023739) | Diagnostic Chemicals , Ltd. | 2003-01-17 |
| CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 (K030012) | Beckman Coulter, Inc. | 2003-01-17 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K030067) | Ortho-Clinical Diagnostics | 2003-01-17 |
| TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS (K030088) | Biosite Incorporated | 2003-01-17 |
| GENZYME CONTRAST II HCG URINE/SERUM TEST (K023544) | Genzyme Corp. | 2003-01-16 |
| MAYBE?MOM MINI OVULATION MICROSCOPE (K013582) | Maybe?Mom | 2003-01-16 |
| ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (K023840) | Bayer Diagnostics Corp. | 2003-01-07 |
| VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 (K023410) | Maine Standards Co. | 2003-01-06 |
| WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (K023744) | Wiener Laboratories Saic | 2003-01-03 |
| CASSETTE/URINE HCG (K023638) | Ind Diagnostic, Inc. | 2003-01-03 |
| MODIFICATION TO ALKP (K023807) | Abbott Laboratories | 2002-12-26 |
| AMMONIA ASSAY FOR THE ADVIA 1650 (K023841) | Bayer Diagnostics Corp. | 2002-12-24 |
| QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 (K023731) | Consolidated Technology | 2002-12-24 |
| RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER (K023784) | Hemagen Diagnostics, Inc. | 2002-12-24 |
| AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (K023396) | Pointe Scientific, Inc., | 2002-12-23 |
| STAT PROFILE PHOX PLUS L ANALYZER (K023567) | Nova Biomedical Corp. | 2002-12-20 |
| ACCESS TOTAL BHCG (K023480) | Beckman Coulter, Inc. | 2002-12-20 |
| MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA (K023669) | Medical Analysis Systems, Inc. | 2002-12-19 |
| COBAS INTEGRA CREATININE PLUS VER.2 ASSAY (K024098) | Roche Diagnostics Corp. | 2002-12-19 |
| ST AIA-PACK TESTOSTERONE ASSAY (K023091) | Tosoh Medics, Inc. | 2002-12-17 |
| MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 (K023867) | Medical Analysis Systems, Inc. | 2002-12-17 |
| ABBOTT ARCHITECT FOLATE (K023397) | Abbott Laboratories | 2002-12-16 |
| PREG-Q EARLY PREGNANCY TEST (K023027) | Yd Diagnostics | 2002-12-16 |
| SAS BLOOD/SERUM/URINE/URINE HCG (K022683) | Sa Scientific, Inc. | 2002-12-16 |
| SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K023832) | Lifescan, Inc. | 2002-12-13 |
| BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 (K023330) | Diagnostic Chemicals , Ltd. | 2002-12-11 |
| MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL (K023928) | Medical Analysis Systems, Inc. | 2002-12-11 |
| VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 (K023875) | Ortho-Clinical Diagnostics, Inc. | 2002-12-10 |
| VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K023876) | Ortho-Clinical Diagnostics, Inc. | 2002-12-10 |
| IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL (K023304) | Diagnostic Products Corp. | 2002-12-09 |
| ACCESS TOTAL T4 ASSAY (K023369) | Beckman Coulter, Inc. | 2002-12-09 |
| WIENER LAB GOT (AST) UV AA LIQUIDA (K023551) | Wiener Laboratories Saic | 2002-12-09 |
| WIENER LAB AMILASA 405 AA LIQUIDA (K023549) | Wiener Laboratories Saic | 2002-12-09 |
| WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (K023550) | Wiener Laboratories Saic | 2002-12-09 |
| BECTON DICKINSON DIABETES SOFTWARE (K023219) | Becton, Dickinson & CO | 2002-12-06 |
| LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS (K023661) | Cliniqa Corporation | 2002-12-06 |
| ELECSYS PROBNP CALCHECK (K020883) | Roche Diagnostics Corp. | 2002-11-29 |
| CLEARBLUE EASY EARLY RESULT PREGNANCY TEST (K023699) | Unipath , Ltd. | 2002-11-27 |
| ACCESS HYPERSENSITIVE HTSH ASSAY (K023093) | Beckman Coulter, Inc. | 2002-11-25 |
| BD VACUTAINER SST II PLUS TUBES (K023331) | Becton, Dickinson & CO | 2002-11-25 |
| BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE (K023075) | Bd Vacutainer Systems Preanalyical Solutions | 2002-11-25 |
| STAT PROFILE CRITICAL CARE XPRESS ANALYZER (K022746) | Nova Biomedical Corp. | 2002-11-22 |
| VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 (K023352) | Maine Standards Co. | 2002-11-22 |
| ASCENSIA DEX 2 DIABETES CARE SYSTEM (K023584) | Bayer Corp. | 2002-11-20 |
| ELECSYS PROBNP IMMUNOASSAY (K022516) | Roche Diagnostics Corp. | 2002-11-19 |
| AMEDITECH IMMUTEST HCG PREGANCY TEST (K023126) | Ameditech, Inc. | 2002-11-18 |
| PTS PANELS LIPID PANEL TEST STRIPS (K023558) | Polymer Technology Systems, Inc. | 2002-11-15 |
| PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS (K023268) | Phoenix Diagnostics, Inc. | 2002-11-15 |
| LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION (K022769) | Bionostics, Inc. | 2002-11-13 |
| INSTANT-VIEW LH OVULATION PREDICTING TEST (K022829) | Alfa Scientific Designs, Inc. | 2002-11-05 |
| RANDOX C-REACTIVE PROTEIN CALIBRATOR (K022682) | Randox Laboratories, Ltd. | 2002-11-05 |
| AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) (K022680) | Azog, Inc. | 2002-11-01 |
| WIENER LAB. BILIRRUBINA TOTAL AA (K022962) | Wiener Laboratories Saic | 2002-11-01 |
| AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) (K022681) | Azog, Inc. | 2002-11-01 |
| MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL (K023307) | Medical Analysis Systems, Inc. | 2002-10-31 |
| NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (K021541) | Perkinelmer Life Sciences | 2002-10-28 |
| MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING (K022941) | Abbott Laboratories | 2002-10-28 |
| CEDIA CYCLOSPORINE PLUS ASSAY (K023208) | Microgenics Corp. | 2002-10-24 |
| SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM (K023194) | Lifescan, Inc. | 2002-10-24 |
| RANDOX APOLIPOPROTEIN CALIBRATOR (K023158) | Randox Laboratories, Ltd. | 2002-10-24 |
| LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE (K023250) | Cliniqa Corporation | 2002-10-17 |
| CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K023065) | Dade Behring, Inc. | 2002-10-16 |
| GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 (K022545) | Hypoguard USA, Inc. | 2002-10-11 |
| SPIFE CK KIT, MODEL 3332, 3333 (K022757) | Helena Laboratories | 2002-10-11 |
| PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) (K022472) | Nichols Institute Diagnostics | 2002-10-09 |
| BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM (K022580) | Becton, Dickinson & CO | 2002-10-09 |
| BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM (K022581) | Becton, Dickinson & CO | 2002-10-09 |
| LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST (K022946) | Princeton BioMeditech Corp. | 2002-10-08 |
| SYNCHRON LX I 725 CLINICAL SYSTEM (K023049) | Beckman Coulter, Inc. | 2002-10-04 |
| LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE (K022867) | Cliniqa Corporation | 2002-10-02 |
| LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE (K022936) | Cliniqa Corporation | 2002-10-02 |
| LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE (K022885) | Cliniqa Corporation | 2002-10-02 |
| SPIFE LD-12 KIT, MODEL 3338 (K022455) | Helena Laboratories | 2002-10-01 |
| SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (K022409) | Spectral Diagnostics, Inc. | 2002-09-30 |
| FASTPACK TESTOSTERONE CALIBRATOR (K022533) | Qualigen, Inc. | 2002-09-30 |