| N/T PROTEIN CONTROL (K032237) | Dade Behring, Inc. | 2003-09-05 |
| CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY (K032159) | Access Bio Incorporate | 2003-09-05 |
| CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (K032027) | Cholestech Corp. | 2003-09-05 |
| HOMOCYSTEINE MICROTITER PLATE ASSAY (K032012) | Diazyme Laboratories | 2003-09-03 |
| I-STAT CARDIAC TROPONIN (CTNI) TEST (K031739) | I-Stat Corporation | 2003-09-02 |
| ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL (K032453) | Bionostics, Inc. | 2003-08-28 |
| LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS (K031921) | Cliniqa Corporation | 2003-08-25 |
| ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (K030860) | Monobind | 2003-08-22 |
| OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 (K032285) | Olympus America, Inc. | 2003-08-21 |
| ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID (K032377) | Roche Diagnostics Corp. | 2003-08-21 |
| ELECSYS PRECICONTROL TROPONIN T (K031990) | Roche Diagnostics Corp. | 2003-08-20 |
| ELECYS SHBG CALCHECK (K031698) | Roche Diagnostics Corp. | 2003-08-20 |
| MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (K032335) | Medical Analysis Systems, Inc. | 2003-08-19 |
| FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT (K030730) | Diagnostics Biochem Canada, Inc. | 2003-08-18 |
| MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K032287) | Beckman Coulter, Inc. | 2003-08-18 |
| AUSAM TOTAL ALBUMIN ASSAY (K013643) | Ausam Biotecthnologies, Inc. | 2003-08-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (K032296) | Ortho-Clinical Diagnostics, Inc. | 2003-08-13 |
| IMMUNICON CELLSAVE PRESERVATIVE TUBE (K030596) | Immunicon Corp. | 2003-08-08 |
| RANDOX LIQUID PROTEIN CALIBRATOR (K031608) | Randox Laboratories, Ltd. | 2003-08-08 |
| VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 (K031924) | Ortho-Clinical Diagnostics | 2003-08-07 |
| LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS (K031577) | Cliniqa Corporation | 2003-08-06 |
| TOX AMMONIA CALIBRATOR (K031683) | Bayer Healthcare, LLC | 2003-08-06 |
| ELECSYS SHBG IMMUNOASSAY (K031717) | Roche Diagnostics Corp. | 2003-08-05 |
| ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS (K031472) | Lifescan, Inc. | 2003-08-05 |
| GLUCOLEADER VALUE (K023279) | Hmd Biomedical, Inc. | 2003-08-04 |
| NICHOLS ADVANTAGE ALDOSTERONE ASSAY (K032188) | Nichols Institute Diagnostics | 2003-07-31 |
| EARLYDETECT MENOPAUSE TEST FOR FSH (K030058) | Early Detect, Inc. | 2003-07-30 |
| CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 (K031534) | Scantibodies Laboratory, Inc. | 2003-07-30 |
| ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC (K032089) | Roche Diagnostics Corp. | 2003-07-30 |
| THYRO TEST (K030912) | Thryotec | 2003-07-25 |
| LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS (K031575) | Cliniqa Corporation | 2003-07-23 |
| COBAS INTEGRA CARBON DIOXIDE ASSAY (K031879) | Roche Diagnostics Corp. | 2003-07-17 |
| AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL (K031880) | Roche Diagnostics Corp. | 2003-07-16 |
| MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (K031890) | Medical Analysis Systems, Inc. | 2003-07-16 |
| ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (K031044) | Clinical Data, Inc. | 2003-07-15 |
| TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS (K030703) | Home Diagnostics, Inc. | 2003-07-11 |
| A/C ENZYMATIC HOMOCYSTEINE ASSAY (K030754) | Anticancer, Inc. | 2003-07-11 |
| AUTION JET AJ-4270 URINE ANALYZER (K030600) | International Remote Imaging Systems | 2003-07-11 |
| COBAS INTEGRA CHOLESTEROL GEN. 2 (K031824) | Roche Diagnostics Corp. | 2003-07-09 |
| PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM (K030076) | Biomed Personal Metabolic and Nutritional Testing | 2003-07-07 |
| FASTPACK FREE T4 IMMUNOASSAY (K030329) | Qualigen, Inc. | 2003-07-03 |
| MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM (K031843) | Medline Industries, Inc. | 2003-07-03 |
| ACCU-CHEK COMPACT TEST STRIP (K031755) | Roche Diagnostics Corp. | 2003-07-03 |
| SECQUIRE CELL SEPARATOR (K024080) | Perfusion Partners & Assoc., Inc. | 2003-07-02 |
| URICHEMTRAK LIQUID ASSAYED URINE CONTROL (K031441) | Medical Analysis Systems, Inc. | 2003-07-01 |
| MAINLINE MAXIE HCG URINE PREGNANCY TEST (K031445) | Mainline Technology, Inc. | 2003-07-01 |
| IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE (K030035) | Diametrics Medical, Inc. | 2003-06-25 |
| BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL (K031644) | Bayer Healthcare, LLC | 2003-06-25 |
| LIPOPROTEIN CALIBRATOR (K031682) | Bayer Healthcare, LLC | 2003-06-25 |
| CALIBRATING MATERIAL, CALIBRATING STANDARDS (K031159) | Diamond Diagnostics, Inc. | 2003-06-25 |
| ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY (K031756) | Roche Diagnostics Corp. | 2003-06-25 |
| BD VIPER INSTRUMENT (K023955) | Becton, Dickinson & CO | 2003-06-24 |
| ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K031038) | Bayer Healthcare, LLC | 2003-06-23 |
| LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS (K031231) | Bio-Rad | 2003-06-18 |
| ONE-STEP PREGNANCY TEST (K031271) | Amerisource Pharmacal, Inc. | 2003-06-17 |
| ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (K030528) | Clinical Data | 2003-06-17 |
| VIDAS TROPONIN I (TNI), MODEL 30 445 (K030950) | bioMerieux, Inc. | 2003-06-16 |
| CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST (K031048) | Access Bio Incorporate | 2003-06-16 |
| RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (K031101) | Hemagen Diagnostics, Inc. | 2003-06-16 |
| CARESTART HCG ONE-STEP PREGNANCY TEST (K031052) | Access Bio Incorporate | 2003-06-13 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY (K031348) | Salimetrics, LLC | 2003-06-10 |
| CALIBRATION PLASMA LMW HEPARIN (K030964) | Instrumentation Laboratory CO | 2003-06-06 |
| GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) (K031135) | Dade Behring, Inc. | 2003-06-02 |
| CRP (II) CALIBRATORS (K030546) | Denka Seiken Co., Ltd. | 2003-06-02 |
| MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (K031364) | Medical Analysis Systems, Inc. | 2003-05-30 |
| EASYCUP (K023823) | Zer Hitech | 2003-05-22 |
| MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM (K031388) | Hypoguard USA, Inc. | 2003-05-22 |
| RANDOX AMMONIA (K030873) | Randox Laboratories, Ltd. | 2003-05-12 |
| ELECSYS LH CALSET II (K031299) | Roche Diagnostics Corp. | 2003-05-12 |
| BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 (K030573) | Bd Vacutainer Systems Preanalyical Solutions | 2003-05-08 |
| CLEARBLUE EASY DIGITAL PREGNANCY TEST (K030659) | Unipath , Ltd. | 2003-05-02 |
| MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (K030942) | Medical Analysis Systems, Inc. | 2003-04-28 |
| PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO (K023256) | Abbott Laboratories | 2003-04-23 |
| POLY STAT SERUM/URINE HCG TEST (K030430) | Alidex, Inc. | 2003-04-18 |
| ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST (K030533) | Cenogenics Corp. | 2003-04-17 |
| STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS (K030650) | Uridynamics, Inc. | 2003-04-14 |
| RDI EXTENDED RANGE CRP CALIBRATOR SET (K030772) | Reference Diagnostics, Inc. | 2003-04-11 |
| GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (K030555) | Biomet, Inc. | 2003-04-11 |
| WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET (K030320) | Wako Chemicals USA, Inc. | 2003-04-11 |
| AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (K030340) | Cytomedix | 2003-04-11 |
| BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR (K030804) | Bayer Healthcare, LLC | 2003-04-10 |
| BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL (K030801) | Bayer Healthcare, LLC | 2003-04-09 |
| MID STREAM PREGNANCY TEST (K023037) | Advanced Diagnostics, Inc. | 2003-04-09 |
| HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (K021622) | Hill-Rom Air-Shields | 2003-04-01 |
| VBL SERUM TROPONIN I TEST, MODEL 1001 (K023505) | Vancouver Biotech , Ltd. | 2003-03-31 |
| EXPRESS BLOOD GLUCOSE MONITORING SYSTEM (K024347) | Hypoguard USA, Inc. | 2003-03-28 |
| CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL (K030705) | Cliniqa Corporation | 2003-03-26 |
| CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL (K030768) | Cliniqa Corporation | 2003-03-21 |
| ATAC CALIBRATOR (K030621) | Elan Diagnostics | 2003-03-19 |
| WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 (K030482) | Wiener Laboratories | 2003-03-19 |
| SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST (K030057) | Spectral Diagnostics, Inc. | 2003-03-19 |
| URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022096) | Bayer Diagnostics Corp. | 2003-03-18 |
| WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 (K024305) | Wiener Laboratories Saic | 2003-03-18 |
| SAS RSV CONTROL KIT (K030628) | Sa Scientific, Inc. | 2003-03-17 |
| MAS LIPID LEVEL 1 AND 2 (K030679) | Medical Analysis Systems, Inc. | 2003-03-14 |
| LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS (K030566) | Cliniqa Corporation | 2003-03-13 |
| ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (K023105) | Elan Diagnostics | 2003-03-13 |
| ATAC PAK MAGNESIUM REAGENT (K030010) | Elan Diagnostics | 2003-03-10 |
| ATAC PAK PHOSPHORUS REAGENT (K030015) | Elan Diagnostics | 2003-03-07 |
| ATAC PAK ALBUMIN REAGENT (K030006) | Elan Diagnostics | 2003-03-07 |