| R&D GLU-LINE HEMATOLOGY CONTROL (K034048) | R&D Systems, Inc. | 2004-03-10 |
| LIQUICHEK CARDIAC MARKER CONTROL LT (K040277) | Bio-Rad Laboratories, Inc. | 2004-03-10 |
| AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 (K033921) | Diagnostic Chemicals , Ltd. | 2004-03-10 |
| DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (K032932) | Stanbio Laboratory | 2004-03-10 |
| VITALAB URIC ACID REAGENT (K040467) | Clinical Data, Inc. | 2004-03-08 |
| MODIFICATION TO E.P.T. PREGNANCY TEST (K040329) | Unipath , Ltd. | 2004-03-08 |
| CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (K040341) | Unipath , Ltd. | 2004-03-08 |
| VITALAB MAGNESIUM REAGENT (K040508) | Clinical Data, Inc. | 2004-03-08 |
| LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS (K040455) | Cliniqa Corporation | 2004-03-05 |
| LYPHOCHEK ASSAYED CHEMISTRY CONTROL (K040273) | Bio-Rad Laboratories, Inc. | 2004-03-04 |
| CALIBRATING MATERIAL, CALIBRATING STANDARDS (K033060) | Diamond Diagnostics, Inc. | 2004-03-04 |
| A1C-CELLULAR (K040025) | Streck Laboratories, Inc. | 2004-03-02 |
| DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) (K033851) | Hypoguard USA, Inc. | 2004-03-02 |
| LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA (K033786) | Ibl GmbH | 2004-02-27 |
| RANDOX URIC ACID (K033278) | Randox Laboratories, Ltd. | 2004-02-27 |
| ELECSYS C-PEPTIDE CALCHECK (K040157) | Roche Diagnostics Corp. | 2004-02-25 |
| LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K040091) | Cliniqa Corporation | 2004-02-23 |
| AXSYM CORTISOL ASSAY (K033731) | Fujirebio Diagnostics,Inc. | 2004-02-20 |
| BAYER SPECIFIC PROTEIN REFERENCE SERUM (K033791) | Bayer Healthcare, LLC | 2004-02-13 |
| ELECSYS C-PEPTIDE CALSET (K033873) | Roche Diagnostics Corp. | 2004-02-13 |
| LIAISON N-TACT PTH (K033426) | DiaSorin, Inc. | 2004-02-12 |
| LIAISON 25 OH VITAMIN D (K032844) | DiaSorin, Inc. | 2004-02-12 |
| POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS (K033706) | Polymedco, Inc. | 2004-02-04 |
| AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 (K030849) | N-Dia, Inc. | 2004-02-02 |
| OLYMPUS URINE CALIBRATOR (K033910) | Cliniqa Corporation | 2004-01-30 |
| PICCOLO MAGNESIUM TEST SYSTEM (K040115) | Abaxis, Inc. | 2004-01-30 |
| CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS (K033058) | Diamond Diagnostics, Inc. | 2004-01-30 |
| GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS (K033055) | Diamond Diagnostics, Inc. | 2004-01-30 |
| ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST (K033606) | Axis-Shield Diagnostics, Ltd. | 2004-01-30 |
| BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT (K033056) | Diamond Diagnostics, Inc. | 2004-01-30 |
| ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (K032199) | Esa, Inc. | 2004-01-30 |
| HOLOTC RIA (K030655) | Axis-Shield Biochemicals, Asa | 2004-01-29 |
| MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (K032235) | Biosite Incorporated | 2004-01-28 |
| NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 (K033302) | Nichols Institute Diagnostics | 2004-01-26 |
| IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (K034055) | Diagnostic Products Corp. | 2004-01-21 |
| LIGAND PLUS CONTROL LEVEL 1-3 (K033344) | Consolidated Technology | 2004-01-16 |
| E.P.T. PREGNANCY TEST (K033658) | Unipath , Ltd. | 2004-01-16 |
| BIOCENTREX CARDIAC PANEL (K033155) | Biocentrex | 2004-01-12 |
| PRECISION XCEED DIABETES MONITORING SYSTEM (K033845) | Abbott Laboratories | 2004-01-08 |
| CO2 CALIBRATOR/DILUENT (K033643) | Bayer Healthcare, Diagnostics Division | 2004-01-08 |
| ELECSYS PRECICONTROL MULTIANALYTE (K033937) | Roche Diagnostics Corp. | 2004-01-07 |
| NOVA GLUCOSE CONTROL SOLUTIONS (K033433) | Nova Biomedical Corp. | 2004-01-02 |
| STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI (K033487) | Dade Behring, Inc. | 2003-12-24 |
| CLINITEST HCG PREGNANCY TEST (K032563) | Bayer Healthcare, LLC | 2003-12-23 |
| TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 (K033383) | Biosite Incorporated | 2003-12-23 |
| BAYER CLINITEK STATUS ANALYZER (K031947) | Bayer Healthcare, LLC | 2003-12-19 |
| INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 (K033603) | Beckman Coulter, Inc. | 2003-12-19 |
| FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 (K031260) | Abbott Diabetes Care, Inc. | 2003-12-19 |
| BAYER SPECIAL CHEMISTRY CONTROLS (K033379) | Bayer Diagnostics Corp. | 2003-12-19 |
| BTG SMARTEST GLUCOSE TEST SYSTEM (K032029) | Bt Medical | 2003-12-18 |
| BAYER RAPIDLAB 1200 SYSTEM (K031560) | Bayer Healthcare, LLC | 2003-12-17 |
| LIGHTCYCLER INSTRUMENT VERSION 1.2 (K033734) | Roche Diagnostics Corp. | 2003-12-17 |
| BAYER SPECIAL CHEMISTRY CALIBRATORS (K033380) | Bayer Diagnostics Corp. | 2003-12-16 |
| IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (K033234) | Diagnostic Products Corp. | 2003-12-12 |
| MISSION CONTROLS (K033063) | Diamond Diagnostics, Inc. | 2003-12-12 |
| HDL-CHOLESTEROL PLUS 2ND GENERATION (K033610) | Roche Diagnostics Corp. | 2003-12-05 |
| RANDOX RX DAYTONA (K024014) | Randox Laboratories, Ltd. | 2003-12-04 |
| QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K033387) | Bio-Rad | 2003-12-02 |
| ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP (K033041) | ACON Laboratories, Inc. | 2003-11-21 |
| OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 (K032665) | Olympus America, Inc. | 2003-11-21 |
| UNIMARK HOME PREGNANCY TEST DEVICE (K032992) | Biotech Atlantic, Inc. | 2003-11-21 |
| MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) (K033501) | Roche Diagnostics Corp. | 2003-11-20 |
| GLUCOSE TOLERANCE BEVERAGE (K032753) | Perk Scientific, Inc. | 2003-11-18 |
| ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 (K032987) | Unotech Diagnostics, Inc. | 2003-11-17 |
| ELECSYS PROBNP IMMUNOASSAY (K032646) | Roche Diagnostics Corp. | 2003-11-12 |
| GOOD MORNING TEST (K031798) | Standard Diagnostics, Inc. | 2003-11-12 |
| DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (K032697) | Dade Behring, Inc. | 2003-11-07 |
| CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE (K033061) | Diamond Diagnostics, Inc. | 2003-11-07 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS (K032993) | Ortho-Clinical Diagnostics, Inc. | 2003-10-31 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS (K033127) | Ortho-Clinical Diagnostics | 2003-10-31 |
| FERTELL FEMALE FERTILITY TEST (K032002) | Genosis, Inc. | 2003-10-30 |
| DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A (K032798) | Dade Behring, Inc. | 2003-10-30 |
| FLUID SAMPLE RETRIEVAL SYSTEM (K030394) | Biomed Personal Metabolic and Nutritional Testing | 2003-10-27 |
| COMBI-SCREEN, MODELS 10SL AND 11SL (K023885) | Analyticon Biotechnologies AG | 2003-10-21 |
| GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM (K032985) | Hmd Biomedical, Inc. | 2003-10-21 |
| GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (K032608) | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 2003-10-21 |
| LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS (K032074) | Cliniqa Corporation | 2003-10-21 |
| GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM (K032819) | Bionostics, Inc. | 2003-10-20 |
| EPT CERTAINTY PREGNANCY TEST (K032939) | Unipath , Ltd. | 2003-10-20 |
| ROCHE DIAGNOSTICS OMNI S ANALYZER (K032311) | Roche Diagnostics Corp. | 2003-10-17 |
| EASYGLUCO, MODEL IGM0002 (K031501) | American Healthcare, Inc. | 2003-10-16 |
| ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 (K033009) | Roche Diagnostics Corp. | 2003-10-16 |
| COBAS INTEGRA ALP IFCC GEN.2 (K033185) | Roche Diagnostics Corp. | 2003-10-14 |
| ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) (K032661) | ACON Laboratories, Inc. | 2003-10-14 |
| LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K033162) | Cliniqa Corporation | 2003-10-10 |
| IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (K032881) | Diagnostic Products Corp. | 2003-10-10 |
| CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS (K032437) | Roche Diagnostics Corp. | 2003-10-08 |
| I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET (K031873) | I-Stat Corporation | 2003-10-07 |
| ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT (K032458) | Abbott Laboratories | 2003-10-06 |
| PHEM-ALERT (K032161) | Femtek,Llc. | 2003-09-30 |
| SENOVA(R) BLOOD GLUCOSE MONITOR (K032076) | Chdiagnostics, LLC | 2003-09-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS (K031031) | Ortho-Clinical Diagnostics, Inc. | 2003-09-29 |
| ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR (K030003) | Elan Diagnostics | 2003-09-29 |
| ATAC TOTAL BILIRUBIN REAGENT (K030014) | Elan Diagnostics | 2003-09-26 |
| ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST (K032510) | ACON Laboratories, Inc. | 2003-09-22 |
| AKERS LABORATORIES INC. BLOOD CELL SEPARATOR (K030815) | Akers Laboratories, Inc. | 2003-09-17 |
| ACCU-CHEK ADVANTAGE SYSTEM (K032552) | Roche Diagnostics Corp. | 2003-09-12 |
| S-MONOVETTE EDTA K2-GEL (K031359) | Sarstedt, Inc. | 2003-09-12 |
| BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K032525) | Bayer Healthcare, LLC | 2003-09-09 |
| AUDIT MICROCONTROLS MICROFD BNP CONTROL (K032122) | Aalto Scientific, Ltd. | 2003-09-09 |