| BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982328) | Bayer Corp. | 1999-01-29 |
| VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (K984303) | Ortho-Clinical Diagnostics, Inc. | 1999-01-28 |
| ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 (K990162) | Bio-Rad | 1999-01-28 |
| ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 (K990161) | Bio-Rad | 1999-01-28 |
| UALB (K983774) | Abbott Laboratories | 1999-01-28 |
| RDI DIRECT LDL CHOLESTEROL TEST (K984107) | Reference Diagnostics, Inc. | 1999-01-28 |
| ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 (K990150) | Bio-Rad | 1999-01-26 |
| ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 (K990149) | Bio-Rad | 1999-01-26 |
| ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 (K990017) | Bio-Rad | 1999-01-25 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS (K990061) | Ortho-Clinical Diagnostics, Inc. | 1999-01-25 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS (K984321) | Ortho-Clinical Diagnostics, Inc. | 1999-01-22 |
| WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR (K984122) | Wako Chemicals USA, Inc. | 1999-01-20 |
| MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (K984425) | Boehringer Mannheim Corp. | 1999-01-20 |
| WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (K984119) | Wako Chemicals USA, Inc. | 1999-01-15 |
| WAKO L-TYPE AMYLASE (K984184) | Wako Chemicals USA, Inc. | 1999-01-13 |
| ORAL-EZE ORAL FLUID COLLECTION SYSTEM (K984361) | Osborn Laboratories, Inc. | 1999-01-13 |
| CARESIDE ALKALINE PHOSPHATASE (K990024) | Careside, Inc. | 1999-01-13 |
| STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK (K984067) | Dade Behring, Inc. | 1999-01-13 |
| DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE (K983849) | Dade Behring, Inc. | 1999-01-11 |
| DUAL VIAL CREATININE REAGENT (K983937) | Intersect Systems, Inc. | 1999-01-06 |
| NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (K982928) | Radiometer America, Inc. | 1999-01-06 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY (K983990) | Ortho-Clinical Diagnostics, Inc. | 1998-12-29 |
| GREINER VACUETTE BLOOD COLLECTION TUBE (K983952) | Greiner Meditech, Inc. | 1998-12-28 |
| AIA-PACK TROPONIN I ASSAY (K984359) | Tosoh Medics, Inc. | 1998-12-23 |
| 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 (K984384) | Thermo Bioanalysis Corp. | 1998-12-23 |
| SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K984014) | Beckman Coulter, Inc. | 1998-12-23 |
| OPTICOAT T3 EIA KIT (K981824) | Biotecx Laboratories, Inc. | 1998-12-22 |
| ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 (K984319) | Bio-Rad | 1998-12-22 |
| CROSSLAPS ELISA (K972788) | Devices and Diagnostics Consulting Group | 1998-12-22 |
| ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 (K984327) | Bio-Rad | 1998-12-22 |
| SYNCHRON SYSTEMS LIPID CALIBRATOR (K983640) | Beckman Coulter, Inc. | 1998-12-21 |
| SUPREME II CONTROL SOLUTIONS (K983432) | Chronimed, Inc. | 1998-12-17 |
| FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (K983468) | Selfcare, Inc. | 1998-12-17 |
| CARESIDE CALCIUM, ORIGINAL (K983789) | Careside, Inc. | 1998-12-17 |
| ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 (K984325) | Bio-Rad | 1998-12-17 |
| LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 (K983807) | Bio-Rad | 1998-12-16 |
| ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 (K984318) | Bio-Rad | 1998-12-15 |
| ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 (K984324) | Bio-Rad | 1998-12-15 |
| ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 (K984323) | Bio-Rad | 1998-12-15 |
| LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 (K984225) | Bio-Rad | 1998-12-14 |
| STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK (K984093) | Dade Behring, Inc. | 1998-12-14 |
| DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR (K984193) | Dade Behring, Inc. | 1998-12-14 |
| ELECSYS CALCHECK TROPONIN T (K984372) | Boehringer Mannheim Corp. | 1998-12-14 |
| AVL OPTI CRITICAL CARE ANALYZER (K984299) | Avl Scientific Corp. | 1998-12-11 |
| AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM (K982076) | Amira Medical, Inc. | 1998-12-10 |
| CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K984277) | Medical Analysis Systems, Inc. | 1998-12-09 |
| ELECSYS TROPONIN T STAT TEST (K984105) | Boehringer Mannheim Corp. | 1998-12-08 |
| PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST (K982303) | Medisense, Inc. | 1998-12-08 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS (K984011) | Ortho-Clinical Diagnostics, Inc. | 1998-12-07 |
| IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 (K983972) | Diagnostic Products Corp. | 1998-12-07 |
| BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY (K983345) | Bayer Corp. | 1998-12-07 |
| LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 (K984071) | Bio-Rad | 1998-12-03 |
| ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503) | Boehringer Mannheim Corp. | 1998-12-01 |
| ABBOTT ARCHEITECT TOTAL B-HCG (K983424) | Abbott Laboratories | 1998-12-01 |
| TERUMO VENOJECT,LUER ADAPTER (K983490) | Terumo Corp. | 1998-11-30 |
| ABBOTT ARCHITECT TOTAL T4 (K983440) | Abbott Laboratories | 1998-11-25 |
| ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 (K984070) | Bio-Rad | 1998-11-25 |
| PRECISET SERUM PROTEINS CALIBRATOR (K983469) | Boehringer Mannheim Corp. | 1998-11-25 |
| ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 (K984073) | Bio-Rad | 1998-11-25 |
| ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 (K984072) | Bio-Rad | 1998-11-24 |
| ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 (K984074) | Bio-Rad | 1998-11-20 |
| ABBOTT ARCHITECT TSH (K983442) | Abbott Laboratories | 1998-11-20 |
| ABBOTT ARCHITECT FREE T3 (K983439) | Abbott Laboratories | 1998-11-20 |
| ABBOTT ARCHITECT TOTAL T3 (K983434) | Abbott Laboratories | 1998-11-20 |
| ABBOTT ARCHITECT FREE T4 (K983417) | Abbott Laboratories | 1998-11-20 |
| DIMENSION AHDL CALIBRATOR (K983850) | Dade Behring, Inc. | 1998-11-18 |
| ACON MIDSTREAM PREGNANCY TEST (K983090) | ACON Laboratories, Inc. | 1998-11-18 |
| BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (K983113) | Syntron Bioresearch, Inc. | 1998-11-18 |
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |
| CARDIAC MARKER CONTROL MODULE, MODEL CCCM (K983971) | Diagnostic Products Corp. | 1998-11-18 |
| 25-HYDROXYVITAMIN D 125I RIA KIT (K983617) | DiaSorin, Inc. | 1998-11-16 |
| SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM (K983517) | Ram Scientific | 1998-11-12 |
| ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 (K983578) | Bio-Rad | 1998-11-12 |
| SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (K983304) | Synermed Intl., Inc. | 1998-11-04 |
| STRATUS CS TROPONIN I CALIBRATOR (K983722) | Dade Behring, Inc. | 1998-11-04 |
| DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR (K983693) | Dade Behring, Inc. | 1998-11-04 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY (K983507) | Ortho-Clinical Diagnostics, Inc. | 1998-11-04 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K983513) | Ortho-Clinical Diagnostics, Inc. | 1998-11-03 |
| CLEARPLAN EASY FERTILITY MONITOR (K981207) | Unipath , Ltd. | 1998-10-28 |
| CHEMSTRIP 101 URINE ANALYZER (K983510) | Boehringer Mannheim Corp. | 1998-10-27 |
| FERRITIN CALIBRATOR (K983548) | Dade Behring, Inc. | 1998-10-27 |
| MG (K981791) | Abbott Laboratories | 1998-10-23 |
| GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE (K982998) | Greiner Meditech, Inc. | 1998-10-21 |
| ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 (K983416) | Boehringer Mannheim Corp. | 1998-10-21 |
| GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE (K982999) | Greiner Meditech, Inc. | 1998-10-16 |
| AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY (K980907) | Axis Biochemicals, Asa | 1998-10-16 |
| BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC (K983492) | Boehringer Mannheim Corp. | 1998-10-09 |
| HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 (K974854) | Morax | 1998-10-07 |
| HEALTH CHECK URI-TEST PROTEIN IN URINE (K972960) | Tcpi, Inc. | 1998-10-07 |
| CHOLESTRON PRO II CHOLESTEROL TEST (K981345) | Lifestream Diagnostics, Inc. | 1998-10-01 |
| UPRO (K981295) | Abbott Laboratories | 1998-10-01 |
| COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT (K982848) | Roche Diagnostic Systems, Inc. | 1998-10-01 |
| LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983130) | Kamiya Biomedical Co. | 1998-09-29 |
| ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983241) | Kamiya Biomedical Co. | 1998-09-29 |
| AST (K983131) | Abbott Laboratories | 1998-09-28 |
| FREE T4 MICROWELL EIA, MODEL #7019 (K982954) | Biomerica, Inc. | 1998-09-24 |
| NBIL (K983134) | Abbott Laboratories | 1998-09-23 |
| WAKO DIRECT LDL-C (K982271) | Wako Chemicals USA, Inc. | 1998-09-22 |
| VACUTAINER BRAND BLOOD COLLECTION SYRINGE (K982922) | Becton Dickinson Vacutainer Systems | 1998-09-22 |
| ELECSYS CALCHECK MYOGLOBIN (K983166) | Boehringer Mannheim Corp. | 1998-09-22 |