| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K042303) | Ortho-Clinical Diagnostics | 2004-09-27 |
| LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (K041349) | Ibl GmbH | 2004-09-24 |
| ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 (K042335) | Bio-Rad Laboratories, Inc. | 2004-09-17 |
| SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 (K042195) | Beckman Coulter, Inc. | 2004-09-16 |
| MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY (K042281) | Beckman Coulter, Inc. | 2004-09-16 |
| MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K042389) | Roche Diagnostics Corp. | 2004-09-14 |
| ABBOTT AXSYM TROPONIN-I ADV (K041811) | Abbott Laboratories | 2004-09-10 |
| FACT PLUS ONE-STEP PREGNANCY TEST KIT (K042280) | Unipath , Ltd. | 2004-09-10 |
| ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST (K042151) | ACON Laboratories, Inc. | 2004-09-09 |
| RANDOX TRI LEVEL CARDIAC CONTROL (K041361) | Randox Laboratories Limited | 2004-09-09 |
| CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR (K041627) | Dako A/S | 2004-09-03 |
| THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT (K041657) | Thermo Electron Corporation | 2004-08-30 |
| ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 (K042005) | Taidoc Technology Corporation | 2004-08-27 |
| VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II (K041720) | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 |
| NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 (DEN040002) | Perkinelmer Life Sciences, Inc. | 2004-08-24 |
| TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM (K042080) | Home Diagnostics, Inc. | 2004-08-19 |
| SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643) | Beckman Coulter, Inc. | 2004-08-18 |
| ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR (K041687) | Abbott Laboratories | 2004-08-18 |
| N LATEX CYSTATIN (K041878) | Dade Behring, Inc. | 2004-08-16 |
| INTERLAB MICROCAL SERUM CONTROLS (K041871) | Trouble Shooter Consuling, Inc. | 2004-08-16 |
| ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE (K041946) | ACON Laboratories, Inc. | 2004-08-16 |
| ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H (K041194) | Medical Analysis Systems, Inc. | 2004-08-16 |
| CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM (K041898) | Cliniqa Corporation | 2004-08-16 |
| ARCHITECT STAT TROPONIN-I IMMUNOASSAY (K041192) | Fisher Diagnostics | 2004-08-12 |
| HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE (K041728) | Immunostics Inc., | 2004-08-11 |
| EZ SMART (K040848) | Vip International Wholesalers, Corp. | 2004-08-11 |
| AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) (K041748) | Azog, Inc. | 2004-08-09 |
| MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) (K041812) | Roche Diagnostics Corp. | 2004-07-27 |
| N APOLIPOPROTEIN STANDARD SERUM (K041870) | Dade Behring, Inc. | 2004-07-27 |
| CYTO-CHEX BCT (K040107) | Streck Laboratories, Inc. | 2004-07-27 |
| PTS PANELS CHOL+GLU TEST PANEL (K041750) | Polymer Technology Systems, Inc. | 2004-07-23 |
| LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (K040923) | Ibl GmbH | 2004-07-22 |
| ARCHITECT STAT CK-MB IMMUNOASSAY (K041596) | Fisher Diagnostics | 2004-07-21 |
| DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 (K041417) | Dade Behring, Inc. | 2004-07-20 |
| OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (K041793) | Olympus America, Inc. | 2004-07-16 |
| TSH-CTK-3 IRMA (K041014) | DiaSorin, Inc. | 2004-07-14 |
| EUSURE BLOOD GLUCOSE MONITORING SYSTEM (K040678) | Eumed Biotechnology Co., Ltd. | 2004-07-14 |
| TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS (K040459) | Biosite Incorporated | 2004-07-06 |
| PTS PANELS LDL CHOLESTEROL TEST STRIPS (K040693) | Polymer Technology Systems, Inc. | 2004-07-06 |
| MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K041133) | Bayer Healthcare, LLC | 2004-07-02 |
| RAICHEM BUN RATE REAGENT (LIQUID) (K041051) | Hemagen Diagnostics, Inc. | 2004-06-30 |
| RAICHEM GLUCOSE UV (LIQUID) (K041052) | Hemagen Diagnostics, Inc. | 2004-06-30 |
| RAICHEM CALCIUM (OCPC) LIQUID REAGENT (K041009) | Hemagen Diagnostics, Inc. | 2004-06-25 |
| TAIDOC CHECK (K041107) | Taidoc Technology Corporation | 2004-06-18 |
| FSH MENOPAUSE PREDICTOR TEST (K041165) | ACON Laboratories, Inc. | 2004-06-17 |
| RANDOX IMMUNOASSAY CONTROL (K040379) | Randox Laboratories, Ltd. | 2004-06-16 |
| POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (K040332) | Arkray, Inc. | 2004-06-16 |
| ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K040425) | Bayer Healthcare, LLC | 2004-06-14 |
| CLEARBLUE EASY EASY READ PREGNANCY TEST (K041404) | Unipath , Ltd. | 2004-06-08 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 (K040813) | Nichols Institute Diagnostics | 2004-06-08 |
| SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT (K040767) | Beckman Coulter, Inc. | 2004-06-07 |
| TOTAL BILIRUBIN REAGENT SET (K040391) | Pointe Scientific, Inc., | 2004-06-02 |
| VENOJECT LUER ADAPTER (K041358) | Terumo Europe N.V. | 2004-05-28 |
| MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K041227) | Roche Diagnostics Corp. | 2004-05-27 |
| VITALAB IRON REAGENT (K033983) | Clinical Data, Inc. | 2004-05-21 |
| Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM (K033627) | Biomedix, Inc. | 2004-05-21 |
| DOCUMENT SALICYLATE CAL VER (K041073) | Microgenics Corp. | 2004-05-21 |
| LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR (K033899) | Lifestream Technologies, Inc. | 2004-05-20 |
| CLINICAL LABORATORY ANALYZING SYSTEM (K041230) | Hemocue, Inc. | 2004-05-20 |
| ONE-STEP PREGNANCY TEST (K041273) | W.H.P.M., Inc. | 2004-05-20 |
| PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (K040575) | Phamatech, Inc. | 2004-05-20 |
| LIQUICHEK TORCH PLUS IGM CONTROL (K040822) | Bio-Rad Laboratories, Inc. | 2004-05-19 |
| PARADIGM LINK BLOOD GLUCOSE METER (K040603) | Becton, Dickinson & CO | 2004-05-19 |
| MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (K033688) | Micro Direct, Inc. | 2004-05-19 |
| LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS (K040927) | Cliniqa Corporation | 2004-05-17 |
| RAMP TROPONIN I ASSAY (K033745) | Response Biomedical Corp. | 2004-05-17 |
| ELECSYS TROPONIN T STAT TEST (K040733) | Roche Diagnostics Corp. | 2004-05-17 |
| WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 (K040918) | Wako Chemicals USA, Inc. | 2004-05-17 |
| RAMP CK-MB ASSAY (K033747) | Response Biomedical Corp. | 2004-05-17 |
| BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 (K041071) | Becton, Dickinson & CO | 2004-05-14 |
| BILIRUBIN ASSAY ON THE OMNI S ANALYZER (K040174) | Roche Diagnostics Corp. | 2004-05-14 |
| AMYLASE LIQUID REAGENT, MODEL A532-200 (K040920) | Teco Diagnostics | 2004-05-10 |
| NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (K041016) | Nova Biomedical Corp. | 2004-05-07 |
| AXSYM CYCLOSPORINE (K040761) | Abbott Laboratories, Inc. | 2004-04-30 |
| QUICKVUE ADVANCE PH AND AMINES GLL TEST (K040008) | Quidel Corp. | 2004-04-29 |
| NORMAL AND HYPERGAMMA CONTROL SERUM (K040925) | Sebia | 2004-04-28 |
| MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (K040880) | Medical Analysis Systems, Inc. | 2004-04-28 |
| KETOCHECKS (K033114) | Neo Diagnostics, Inc. | 2004-04-26 |
| AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR (K033860) | Wako Chemicals USA, Inc. | 2004-04-23 |
| ACCU-CHEK GO SYSTEM (K040796) | Roche Diagnostics Corp. | 2004-04-22 |
| NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY (K033727) | Nichols Institute Diagnostics | 2004-04-22 |
| MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM (K040814) | Abbott Laboratories | 2004-04-15 |
| OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 (K040692) | Olympus America, Inc. | 2004-04-08 |
| NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) (K040352) | Bioresource Technology, Inc. | 2004-04-02 |
| CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF (K040264) | Roche Diagnostics Corp. | 2004-04-02 |
| LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS (K040535) | Cliniqa Corporation | 2004-03-29 |
| MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL (K040670) | Home Diagnostics, Inc. | 2004-03-25 |
| PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM (K040628) | Abbott Laboratories | 2004-03-25 |
| WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET (K040226) | Wako Chemicals USA, Inc. | 2004-03-25 |
| ACCESS DHEA-S REAGENT ASSAY (K040181) | Beckman Coulter, Inc. | 2004-03-24 |
| CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) (K040245) | Roche Diagnostics Corp. | 2004-03-24 |
| TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) (K032657) | Home Diagnostics, Inc. | 2004-03-24 |
| ZAP HCG TEST, MODEL 8001 (K033297) | Zbx Corporation | 2004-03-18 |
| VITALAB DIRECT BILIRUBIN REAGENT (K040631) | Clinical Data, Inc. | 2004-03-18 |
| DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR (K032936) | Stanbio Laboratory | 2004-03-12 |
| RANDOX LIQUID CRP CONTROLS (K040351) | Randox Laboratories, Ltd. | 2004-03-12 |
| VITALAB AMYLASE REAGENT (K040534) | Clinical Data, Inc. | 2004-03-11 |
| PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS (K040280) | Roche Diagnostics Corp. | 2004-03-11 |
| VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (K034000) | Clinical Data, Inc. | 2004-03-10 |
| OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 (K040471) | Olympus America, Inc. | 2004-03-10 |