| MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL (K021155) | Medical Analysis Systems, Inc. | 2002-04-29 |
| GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) (K020208) | Bayer Group Diagnostics | 2002-04-29 |
| CALIBRATING MATERIAL, CAL-PAK, BUFFERS (K020894) | Mission Diagnostics | 2002-04-29 |
| CARESIDE TRGLYCERIDE (K020488) | Careside, Inc. | 2002-04-15 |
| LIQUICHEK URINE CHEMISTRY CONTROL (K020817) | Bio-Rad Laboratories, Inc. | 2002-04-12 |
| ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS (K020575) | Elan Diagnostics | 2002-04-12 |
| MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS (K020662) | Ortho-Clinical Diagnostics | 2002-04-12 |
| CHEMISTRY CALIBRATOR (K020454) | Jas Diagnostics, Inc. | 2002-04-08 |
| FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 (K020548) | Monobind | 2002-04-05 |
| SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (K012221) | Biosafe Laboratories, Inc. | 2002-04-03 |
| HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (K020935) | Hemocue, Inc. | 2002-04-03 |
| SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 (K020467) | Helena Laboratories | 2002-03-29 |
| 1,25-DIHYDROXYVITAMIN D125I RIA (K014030) | DiaSorin, Inc. | 2002-03-26 |
| CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS (K020596) | Diamond Diagnostics, Inc. | 2002-03-23 |
| DIABETES ASSISTANT SOFTWARE (K014139) | Roche Diagnostics Corp. | 2002-03-21 |
| VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 (K020450) | Maine Standards Co. | 2002-03-21 |
| URS-IG (GLUCOSE TEST) (K020175) | Teco Diagnostics | 2002-03-21 |
| IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 (K020237) | Consolidated Technology | 2002-03-19 |
| ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY (K020217) | Bayer Diagnostics Corp. | 2002-03-15 |
| SAS VALUE HCG (K020438) | Sa Scientific, Inc. | 2002-03-08 |
| MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K013662) | Quantimetrix Corp. | 2002-03-08 |
| ELECSYS ANTI-TG CALCHECK (K020369) | Roche Diagnostics Corp. | 2002-03-06 |
| MODIFICATION TO VIGIL LIPID CONTROL (K020521) | Beckman Coulter, Inc. | 2002-03-01 |
| ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 (K020128) | Diagnostic Systems Laboratories, Inc. | 2002-03-01 |
| SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS (K012975) | Abbott Laboratories | 2002-02-28 |
| STAT PROFILE PHOX ANALYZER (K014295) | Nova Biomedical Corp. | 2002-02-28 |
| JAS AMYLASE LIQUID REAGENT (K020282) | Jas Diagnostics, Inc. | 2002-02-28 |
| CLEARPLANE EASY OVULATION TEST (K013874) | Unipath , Ltd. | 2002-02-19 |
| LIBERTY BLOOD GLUCOSE MONITORING SYSTEM (K014167) | Polymedica Pharmaceuticals, U.S.A., Inc.] | 2002-02-19 |
| EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. (K013342) | Chay Medical, LLC | 2002-02-15 |
| PACIFIC HEMOSTASIS REFERENCE EMULSION (K013397) | Fisher Diagnostics | 2002-02-15 |
| HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM (K020232) | Hypoguard USA, Inc. | 2002-02-12 |
| OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA (K014032) | Olympus America, Inc. | 2002-02-08 |
| OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA (K014015) | Olympus America, Inc. | 2002-02-08 |
| TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) (K014120) | Diagnostics Biochem Canada, Inc. | 2002-02-08 |
| pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (K020148) | Phoenix Diagnostics, Inc. | 2002-02-04 |
| SPECTRAL'S TROPONIN I (K014105) | Spectral Diagnostics, Inc. | 2002-02-01 |
| BD VACUTAINER SAFETY COAGULATION TUBE (K013971) | Becton, Dickinson & CO | 2002-02-01 |
| ROCHE COBAS TAQMAN ANALYZER (K012966) | Roche Molecular Systems, Inc. | 2002-02-01 |
| VACUETTE EDTA K2 TUBES (K014104) | Greiner Vacuette North America, Inc. | 2002-02-01 |
| PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE (K020129) | Phoenix Diagnostics, Inc. | 2002-02-01 |
| CORTISOL LIA (K010790) | Kmi Diagnostics, Inc. | 2002-01-29 |
| IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (K013938) | Diametrics Medical, Inc. | 2002-01-28 |
| SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR (K014103) | Beckman Coulter, Inc. | 2002-01-28 |
| WIENER LAB. ALP 405 (K013983) | Wiener Laboratories Saic | 2002-01-28 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS (K013899) | Ortho-Clinical Diagnostics | 2002-01-24 |
| AIMSTEP PREGNANCY (K013857) | Germaine Laboratories, Inc. | 2002-01-22 |
| CREATINE KINASE (CK-NAC) (K013912) | Jas Diagnostics, Inc. | 2002-01-18 |
| AUTION MAX AX-4280 URINALYSIS SYSTEM (K013783) | International Remote Imaging Systems | 2002-01-18 |
| THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE (K012943) | Quantech , Ltd. | 2002-01-18 |
| MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (K012789) | Morax | 2002-01-17 |
| SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT (K013978) | Beckman Coulter, Inc. | 2002-01-15 |
| STAT PROFILE PHOX BASIC ANALYZER (K013729) | Nova Biomedical Corp. | 2002-01-15 |
| BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT (K013062) | Biocheck, Inc. | 2002-01-08 |
| VICTORCH MEDITEK'S HCG TEST CARD (K013678) | Victorch Meditek, Inc. | 2001-12-27 |
| VICTORCH HCG TEST STRIP (K013702) | Victorch Meditek, Inc. | 2001-12-27 |
| MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL (K013995) | Medical Analysis Systems, Inc. | 2001-12-21 |
| ACS 180 HOMOCYSTEINE ASSAY (K013606) | Bayer Diagnostics Corp. | 2001-12-21 |
| STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE (K013850) | Diamond Diagnostics, Inc. | 2001-12-21 |
| UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371) | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K013900) | Ortho-Clinical Diagnostics | 2001-12-21 |
| SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (K013466) | Helena Laboratories | 2001-12-21 |
| BIOSCANNER PLUS (K014099) | Polymer Technology Systems, Inc. | 2001-12-21 |
| WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 (K013652) | Wiener Laboratories Saic | 2001-12-21 |
| AST (SGOT) (K013698) | Jas Diagnostics, Inc. | 2001-12-21 |
| WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA (K011953) | Wiener Laboratories Saic | 2001-12-21 |
| PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (K013451) | Phoenix Diagnostics, Inc. | 2001-12-18 |
| MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (K014034) | Beckman Coulter, Inc. | 2001-12-18 |
| MODIFICATION TO ALPHA DX SYSTEM (K014024) | First Medical, Inc. | 2001-12-18 |
| INVERNESS MEDICAL EARLY PREGNANCY TEST (K013907) | Cambridge Diagnostics Ireland, Ltd. | 2001-12-18 |
| DC-UIBC-CO2-CAL, MODEL SE-153 (K013178) | Diagnostic Chemicals , Ltd. | 2001-12-18 |
| ADVIA CENTAUR HOMOCYSTEINE ASSAY (K013406) | Bayer Diagnostics Corp. | 2001-12-18 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 (K011323) | Salimetrics, LLC | 2001-12-17 |
| AIA-PACK CTNI 2ND-GEN ASSAY (K012820) | Tosoh Medics, Inc. | 2001-12-14 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY (K013992) | Nichols Institute Diagnostics | 2001-12-13 |
| MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL (K013734) | Medical Analysis Systems, Inc. | 2001-12-07 |
| TCI-31 LIFELONG OVULATION TESTER (K013323) | Tci New York | 2001-12-05 |
| MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM (K012014) | Abbott Diabetes Care, Inc. | 2001-12-05 |
| ACCU-CHEK ACTIVE TEST SYSTEM (K012324) | Roche Diagnostics Corp. | 2001-12-05 |
| ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K011479) | Inverness Medical Innovations, Inc. | 2001-11-30 |
| WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. (K013145) | Wiener Laboratories Saic | 2001-11-27 |
| VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 (K013265) | Maine Standards Co. | 2001-11-20 |
| LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE (K013332) | Cliniqa Corporation | 2001-11-20 |
| IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 (K013566) | Diagnostic Products Corp. | 2001-11-20 |
| BIOSCANNER 2000 (K013068) | Polymer Technology Systems, Inc. | 2001-11-20 |
| ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY (K011963) | Bayer Corp. | 2001-11-20 |
| WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA (K013101) | Wiener Laboratories Saic | 2001-11-16 |
| BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS (K013203) | Polymer Technology Systems, Inc. | 2001-11-16 |
| VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 (K013119) | Maine Standards Co. | 2001-11-16 |
| WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (K013095) | Wiener Laboratories Saic | 2001-11-16 |
| WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 (K013102) | Wiener Laboratories Saic | 2001-11-13 |
| WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 (K013097) | Wiener Laboratories Saic | 2001-11-13 |
| N LP(A) STANDARD SY (K013126) | Dade Behring, Inc. | 2001-11-09 |
| ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS (K013152) | Elan Holdings, Inc. | 2001-11-09 |
| CLEARBLUE EASY EARLY RESULT PREGNANCY TEST (K013372) | Unipath , Ltd. | 2001-11-09 |
| WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 (K012326) | Wiener Laboratories Saic | 2001-11-08 |
| PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER (K012987) | Phoenix Diagnostics, Inc. | 2001-11-07 |
| OMNI C ANALYZER (K013373) | Roche Diagnostics Corp. | 2001-11-02 |
| STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS (K012829) | Biocare Corp. | 2001-11-02 |
| GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE (K013147) | Bionostics, Inc. | 2001-10-24 |