| OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) (K050423) | Roche Diagnostics | 2005-04-22 |
| URISCAN OPTIMA II URINE ANALYZER (K050801) | Yd Diagnostics | 2005-04-20 |
| VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (K042927) | Greiner Bio-One Vacuette North America | 2005-04-15 |
| OSOM HCG COMBO TEST (K043385) | Genzyme Diagnostics | 2005-04-12 |
| ONE STEP HCG URINE PREGNANCY TEST (K043443) | Guangzhou Wondfo Biotech Co., Ltd. | 2005-04-08 |
| BLOOD GLUCOSE MONITORING SYSTEM (K043543) | American Healthcare, Inc. | 2005-04-08 |
| EASYGLUCO IGM-0002 G2 (K043512) | American Healthcare, Inc. | 2005-04-08 |
| SPOTCHEM II CREATININE, AMYLASE & ALP TESTS (K050652) | Arkray, Inc. | 2005-04-06 |
| PREGNANCY-SKREEN (K050328) | Biochemical Diagnostic, Inc. | 2005-03-29 |
| ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 (K041881) | Hypoguard USA, Inc. | 2005-03-25 |
| VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS (K050504) | Maine Standards Co. | 2005-03-25 |
| QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL (K050536) | Bio-Rad | 2005-03-24 |
| RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 (K050125) | More Diagnostics | 2005-03-18 |
| CEDIA TACROLIMUS ASSAY (K050206) | Microgenics Corp. | 2005-03-15 |
| STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (K042169) | Stanbio Laboratory | 2005-03-14 |
| CLEVER CHEK TD-3213 (K042795) | Taidoc Technology Corporation | 2005-03-07 |
| RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER (K050100) | Bionostics, Inc. | 2005-02-25 |
| MOMENTS MENOPAUSE CHECK, MODEL 9113 (K043599) | Phamatech, Inc. | 2005-02-25 |
| MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE (K050191) | Becton, Dickinson & CO | 2005-02-22 |
| PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 (K040958) | Tokyo Boeki Medical System , Ltd. | 2005-02-15 |
| SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (K050077) | Arkray, Inc. | 2005-02-15 |
| STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT (K043476) | Dade Behring, Inc. | 2005-02-15 |
| SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 (K043268) | Randox Laboratories, Ltd. | 2005-02-15 |
| RANDOX URINE CONTROLS (K043266) | Randox Laboratories, Ltd. | 2005-02-15 |
| POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 (K043267) | Randox Laboratories, Ltd. | 2005-02-10 |
| CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K050202) | Beckman Coulter, Inc. | 2005-02-09 |
| LIQUICHEK BNP CONTROL (K043584) | Bio-Rad Laboratories, Inc. | 2005-02-08 |
| OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 (K043460) | Olympus America, Inc. | 2005-01-31 |
| PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC (K050026) | Roche Diagnostics | 2005-01-31 |
| LDL-EX SEIKEN ASSAY KIT (K043264) | Denka Seiken Co., Ltd. | 2005-01-26 |
| DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (K043546) | Dade Behring, Inc. | 2005-01-18 |
| LIQUID ASSAYED MULTIQUAL CONTROL (K043208) | Bio-Rad | 2005-01-07 |
| CHEMVIEW-10 (K042641) | Cenogenics Corp. | 2005-01-07 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K042678) | Bionime Corporation | 2005-01-03 |
| DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT (K043378) | Drew Scientific , Ltd. | 2004-12-29 |
| MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 (K042362) | Diagnostic Chemicals , Ltd. | 2004-12-27 |
| GLUCOSE OXIDASE, GLUCOSE (K040974) | Genchem, Inc. | 2004-12-27 |
| GENCHEM ELECTROLYTE BUFFER (K040977) | Genchem, Inc. | 2004-12-27 |
| CALCIUM, AZO DYE REAGENT (K040972) | Genchem, Inc. | 2004-12-27 |
| GENCHEM CREATININE REAGENT (K040976) | Genchem, Inc. | 2004-12-27 |
| GENCHEM CO2 ACID REAGENT (K040975) | Genchem, Inc. | 2004-12-27 |
| BUN REAGENT (K040973) | Genchem, Inc. | 2004-12-27 |
| OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 (K043202) | Olympus America, Inc. | 2004-12-23 |
| AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM (DEN040012) | Affymetrix, Inc. | 2004-12-23 |
| MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318) | Roche Diagnostics Corp. | 2004-12-23 |
| ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM (K043158) | Bayer Healthcare, LLC | 2004-12-22 |
| GENCHEM ISE ELECTROLYTE REFERENCE (K040971) | Genchem, Inc. | 2004-12-22 |
| ASCENSIA ELITE DIABETES CARE SYSTEM (K043311) | Bayer Healthcare, LLC | 2004-12-22 |
| NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY (K042676) | Nichols Institute Diagnostics | 2004-12-17 |
| BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 (K041619) | Biocheck, Inc. | 2004-12-17 |
| MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II (K043320) | Roche Diagnostics Corp. | 2004-12-17 |
| AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET (K042318) | Aalto Scientific, Ltd. | 2004-12-09 |
| NICHOLS ADVANTAGE CORTISOL (K042689) | Nichols Institute Diagnostics | 2004-12-09 |
| VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II (K042838) | Ortho-Clinical Diagnostics, Inc. | 2004-12-09 |
| LIQUID STABLE HBA1C CONTROL (K043070) | Canterbury Scientific , Ltd. | 2004-12-09 |
| LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL (K043108) | Bio-Rad Laboratories, Inc. | 2004-12-07 |
| OLYMPUS LACTATE, OSR6193 (K042406) | Olympus America, Inc. | 2004-12-03 |
| GAMMA-B 1,25-DIHYDROXY VITAMIN D (K042519) | Immunodiagnostic Systems , Ltd. | 2004-12-01 |
| SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL (K042443) | Arkray, Inc. | 2004-11-24 |
| THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS (K041427) | Arkray, Inc. | 2004-11-24 |
| ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE (K043175) | Roche Diagnostics Corp. | 2004-11-24 |
| HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 (K041926) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| ROCHE DIAGNOSTICS ELECSYS AFP CALSET II (K043095) | Roche Diagnostics Corp. | 2004-11-23 |
| LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (K041927) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (K041928) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (K042473) | Cobe Cardiovascular, Inc. | 2004-11-19 |
| INSTANT-VIEW TROPONIN I TEST (K042227) | Alfa Scientific Designs, Inc. | 2004-11-19 |
| MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD (K042347) | Dade Behring, Inc. | 2004-11-19 |
| VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS (K042521) | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 |
| QUIKREAD CRP CALIBRATOR SET (K042625) | Orion Diagnostica, OY | 2004-11-18 |
| MULTI-CHEM CALIBRATOR A (K042551) | Wako Chemicals USA, Inc. | 2004-11-16 |
| UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS (K042291) | Beckman Coulter, Inc. | 2004-11-12 |
| MULTI-LIPID CALIBRATOR (K042550) | Wako Chemicals USA, Inc. | 2004-11-08 |
| MULTI CHEM CAL B (K042549) | Wako Chemicals USA, Inc. | 2004-11-08 |
| QUEST TUMOR MARKER CONTROL, MODEL 955 (K042815) | Bio-Rad | 2004-11-05 |
| MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL (K042717) | Medical Analysis Systems, Inc. | 2004-11-05 |
| ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (K042307) | Seradyn, Inc. | 2004-11-03 |
| LIQUICHEK ELEVATED CRP CONTROL (K042837) | Bio-Rad | 2004-11-02 |
| QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (K042446) | Bio-Rad Laboratories, Inc. | 2004-11-02 |
| HDL-EX SEIKEN ASSAY KIT (K041090) | Denka Seiken Co., Ltd. | 2004-10-29 |
| DIAZYME POTASSIUM ENZYMATIC ASSAY KIT (K042191) | Diazyme Laboratories | 2004-10-29 |
| DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT (K042448) | General Atomics | 2004-10-29 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE (K042006) | Ortho-Clinical Diagnostics, Inc. | 2004-10-28 |
| BIO-CHEM ANALYZER, MODEL 100 (K040750) | Clinical Analysis Corporation, Inc. | 2004-10-28 |
| BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR (K041478) | Becton Dickinson | 2004-10-28 |
| GLUCOSE TOLERANCE BEVERAGE (K042183) | Ever Scientific | 2004-10-27 |
| FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST (K040866) | Armkel, LLC | 2004-10-19 |
| VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 (K041975) | Maine Standards Co. | 2004-10-15 |
| ABL800 FLEX (K041874) | Radiometer Medical Aps | 2004-10-08 |
| DIAZYME SODIUM ENZYMATIC ASSAY (K042189) | Diazyme Laboratories | 2004-10-07 |
| LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 (K042324) | Bio-Rad | 2004-10-07 |
| STAT K IN VITRO DIAGNOSTIC TEST SYSTEM (K042270) | Stat Chem, Inc. | 2004-10-06 |
| FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K042651) | Beckman Coulter, Inc. | 2004-10-05 |
| MICROALBUMIN MULTI-CALIBRATOR SET (K042243) | Diagnostic Chemicals , Ltd. | 2004-10-04 |
| DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K042424) | Wallac OY | 2004-09-30 |
| AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K042425) | Wallac OY | 2004-09-30 |
| ELECSYS FOLATE II CALSET II (K042490) | Roche Diagnostics Corp. | 2004-09-30 |
| ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) (K041866) | Axis-Shield Diagnostics, Ltd. | 2004-09-29 |
| ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE (K042015) | Bayer Healthcare, Diagnostics Division | 2004-09-29 |
| HEMOSIL CALIBRATION PLASMA (K041905) | Instrumentation Laboratory CO | 2004-09-28 |