| LDL CHOLESTEROL (AUTOMATED) (K022519) | Jas Diagnostics, Inc. | 2002-09-30 |
| ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 (K021814) | Beckman Coulter, Inc. | 2002-09-27 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS (K022901) | Ortho-Clinical Diagnostics | 2002-09-27 |
| PH AND AMINES EXTERNAL CONTROL SET (K022851) | Quidel Corp. | 2002-09-27 |
| PTS PANELS LIPID PANEL TEST STRIPS (K022898) | Polymer Technology Systems, Inc. | 2002-09-24 |
| FERTILITE OV (K020808) | Pheromone Sciences Corp. | 2002-09-23 |
| CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 (K022725) | Good Biotech Corp. | 2002-09-23 |
| MY ALLERGY TEST (K021698) | Immunetech Corporation | 2002-09-19 |
| RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (K022772) | Hemagen Diagnostics, Inc. | 2002-09-17 |
| LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 (K022991) | Bio-Rad | 2002-09-17 |
| POCKETCHEM UA AUTION STICKS 10TA (K022386) | Arkray, Inc. | 2002-09-17 |
| LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER (K022758) | Cliniqa Corporation | 2002-09-17 |
| TOTAL BILIRUBIN (K022339) | Abbott Laboratories | 2002-09-13 |
| SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K022724) | Lifescan, Inc. | 2002-09-12 |
| MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET (K022875) | Becton, Dickinson & CO | 2002-09-11 |
| IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) (K022158) | Instrumentation Laboratory CO | 2002-09-10 |
| WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 (K021334) | Wiener Laboratories Saic | 2002-09-10 |
| MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM (K022182) | Abbott Laboratories | 2002-09-09 |
| ELECSYS CORTISOL TEST SYSTEM (K021218) | Roche Diagnostics Corp. | 2002-09-09 |
| DIRECT BILIRUBIN (K022180) | Abbott Laboratories | 2002-09-06 |
| PICCOLO PHOSPHORUS TEST SYSTEM (K022312) | Abaxis, Inc. | 2002-09-05 |
| RAICHEM LIPID CALIBRATOR (K022767) | Hemagen Diagnostics, Inc. | 2002-09-03 |
| EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS (K021781) | Chay Medical, LLC | 2002-08-30 |
| RANDOX LIPID CONTROL (K022591) | Randox Laboratories, Ltd. | 2002-08-30 |
| MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (K022654) | Roche Diagnostics Corp. | 2002-08-29 |
| LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K022491) | Cliniqa Corporation | 2002-08-27 |
| ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM (K021819) | Lifescan, Inc. | 2002-08-23 |
| IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (K022538) | Diagnostic Chemicals, Ltd. (Usa) | 2002-08-23 |
| PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS (K022072) | Precision Systems, Inc. | 2002-08-23 |
| FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY (K021972) | Qualigen, Inc. | 2002-08-21 |
| IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (K022603) | Diagnostic Products Corp. | 2002-08-21 |
| PTS PANELS MULTI-CHEMISTRY CONTROLS (K022401) | Polymer Technology Systems, Inc. | 2002-08-21 |
| PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY (K021960) | Abbott Laboratories | 2002-08-16 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 (K022529) | Bio-Rad | 2002-08-15 |
| SPIFE LIPPOROTEIN-12, MODEL 3344 (K022333) | Helena Laboratories | 2002-08-15 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 (K022525) | Bio-Rad | 2002-08-15 |
| MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 (K021902) | Medtronic Vascular | 2002-08-12 |
| BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 (K022426) | Becton, Dickinson & CO | 2002-08-08 |
| POLY STAT HCG DIPSTICK TEST (K021386) | Alidex, Inc. | 2002-08-05 |
| CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 (K022232) | Cliniqa Corporation | 2002-08-01 |
| BD VACUTAINER PLUS PST II TUBE (K022130) | Becton, Dickinson & CO | 2002-07-29 |
| STAT PROFILE PHOX PLUS C ANALYZER (K021713) | Nova Biomedical Corp. | 2002-07-25 |
| THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 (K022108) | Thermo Dma, Inc. | 2002-07-25 |
| ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR (K021316) | Genzyme Corp. | 2002-07-25 |
| J&S MEDICAL SENTRY URINE DIPSTICK CONTROL (K022085) | J & S Medical Assoc., Inc. | 2002-07-25 |
| ACCU-CHEK COMPACT SYSTEM (K022171) | Roche Diagnostics Corp. | 2002-07-23 |
| CALIBRATING MATERIAL, BUFFERS, STANDARD (K022027) | Mission Diagnostics | 2002-07-22 |
| IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (K022118) | Diagnostic Products Corp. | 2002-07-22 |
| MODIFICATION TO RAICHEM CALCIUM REAGENT (K022049) | Hemagen Diagnostics, Inc. | 2002-07-19 |
| CHEMWELL, ALSO KNOWN AS PROJECT 2900 (K013420) | Awareness Technology, Inc. | 2002-07-19 |
| JAS HDL CHOLESTEROL (AUTOMATED) REAGENT (K021671) | Jas Diagnostics, Inc. | 2002-07-19 |
| VIDAS TESTOSTERONE (TES), MODEL 30 418 (K021326) | bioMerieux, Inc. | 2002-07-18 |
| ALBUMIN REAGENT (K021636) | Intersect Systems, Inc. | 2002-07-17 |
| EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER (K021515) | Medica Corp. | 2002-07-16 |
| LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 (K022041) | Bio-Rad Laboratories, Inc. | 2002-07-16 |
| LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD (K020968) | Pan Probe Biotech, Inc. | 2002-07-15 |
| AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K021151) | Bayer Diagnostics Corp. | 2002-07-13 |
| GLUCOSE CONTROL SOLUTION FOR BD LATITUDE (K021697) | Bionostics, Inc. | 2002-07-12 |
| RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 (K021624) | Bionostics, Inc. | 2002-07-12 |
| ATAC PAK BUN REAGENT (K021385) | Elan Diagnostics | 2002-07-12 |
| HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (K022053) | Sebia | 2002-07-12 |
| PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM (K021927) | Biomet, Inc. | 2002-07-12 |
| CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (K021428) | Bayer Corp. | 2002-07-05 |
| WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA (K021332) | Wiener Laboratories Saic | 2002-07-03 |
| CARESIDE LDH (K020484) | Careside, Inc. | 2002-07-03 |
| MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM (K021827) | Roche Diagnostics Corp. | 2002-07-03 |
| POLY-CHEM GLUCOSE (K020852) | Polymedco, Inc. | 2002-07-03 |
| SAMPLOK LUER KIT (K021941) | Itl Corporation Pty, Ltd. | 2002-07-02 |
| TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (K021317) | Biosite Incorporated | 2002-07-01 |
| CARESIDE GGT (K020486) | Careside, Inc. | 2002-07-01 |
| ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM (K021943) | Lifescan, Inc. | 2002-06-28 |
| ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR (K021535) | Bayer Diagnostics Corp. | 2002-06-27 |
| ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR (K021532) | Bayer Diagnostics Corp. | 2002-06-27 |
| RDI HS CRP CALIBRATOR SET (K021607) | Reference Diagnostics, Inc. | 2002-06-27 |
| MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL (K021930) | Bionostics, Inc. | 2002-06-25 |
| CHOLESTEROL 1, 2, 3 (K014018) | Imi | 2002-06-24 |
| DIMENSION TPSA CALIBRATOR, MODEL #RC459 (K020980) | Dade Behring, Inc. | 2002-06-21 |
| QUPID PLUS E.R. (K020378) | Stanbio Laboratory | 2002-06-21 |
| ACCU-CHEK ADVANTAGE MODULE (K021513) | Roche Diagnostics Corp. | 2002-06-11 |
| FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM (K020866) | Abbott Diabetes Care, Inc. | 2002-06-11 |
| STAT PROFILE CRITICAL CARE XPRESS ANALYZER (K020297) | Nova Biomedical Corp. | 2002-06-10 |
| MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 (K021381) | Dade Behring, Inc. | 2002-06-10 |
| PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (K013654) | Precision Systems, Inc. | 2002-06-05 |
| CARESIDE ALT (K020487) | Careside, Inc. | 2002-06-04 |
| PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS (K020364) | Phoenix Diagnostics, Inc. | 2002-06-04 |
| MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM (K021448) | Roche Diagnostics Corp. | 2002-06-03 |
| ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 (K021032) | Scantibodies Laboratory, Inc. | 2002-06-03 |
| AXSYM INTACT PTH, MODEL 2G06 (K020945) | Diagnostic Systems Laboratories, Inc. | 2002-05-31 |
| LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (K021498) | Bio-Rad | 2002-05-24 |
| AT HOME OVULATION TEST, MODEL 9032 (K021409) | Phamatech, Inc. | 2002-05-24 |
| SPECTRAL'S 2 IN 1 (TNI-MYO) (K020950) | Spectral Diagnostics, Inc. | 2002-05-24 |
| STATUS HCG SERUM/URINE (K020439) | Princeton BioMeditech Corp. | 2002-05-23 |
| QUICKVUE ONE-STEP HCG-COMBO (K020801) | Quidel Corp. | 2002-05-17 |
| QUICKVUE ONE-STEP HCG-URINE (K020799) | Quidel Corp. | 2002-05-17 |
| IRON-PC-SL ASSAY MODEL # 151-10, 151-26 (K020816) | Diagnostic Chemicals , Ltd. | 2002-05-14 |
| OCTEIA 25-HYDROXY VITAMIN D (K021163) | Immunodiagnostic Systems , Ltd. | 2002-05-10 |
| DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 (K020724) | Dade Behring, Inc. | 2002-05-09 |
| DIMENSION ALDL CALIBRATOR, MODEL DC131 (K020723) | Dade Behring, Inc. | 2002-05-08 |
| SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (K020625) | Helena Laboratories | 2002-05-06 |
| GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) (K020210) | Bayer Group Diagnostics | 2002-04-30 |