| JM-102 JAUNDICE METER (K972309) | Air-Shields, Inc. | 1998-09-22 |
| UPRO (K981682) | Abbott Laboratories | 1998-09-21 |
| RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR (K982767) | Raichem | 1998-09-21 |
| TBIL (K983133) | Abbott Laboratories | 1998-09-16 |
| UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (K981573) | United Biotech, Inc. | 1998-09-15 |
| HDLC PRECIPITATING REAGENT (K982539) | Ac Biochemicals, Inc. | 1998-09-15 |
| CARBON DIOXIDE-SL ASSAY, CAT # 253-01 (K983019) | Diagnostic Chemicals , Ltd. | 1998-09-14 |
| UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL (K972382) | Arrows Co., Ltd. | 1998-09-14 |
| LACTATE PRO SYSTEM (K980908) | Kdk Corp. | 1998-09-11 |
| RANDOX DIRECT LDL CHOLESTEROL (K982529) | Randox Laboratories, Ltd. | 1998-09-11 |
| N-ASSAY GLU-UL (K980883) | Crestat Diagnostics, Inc. | 1998-09-03 |
| SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (K982491) | Sangui Biotech, Inc. | 1998-09-03 |
| SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM (K981973) | Ram Scientific | 1998-09-03 |
| ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS (K982089) | Boehringer Mannheim Corp. | 1998-09-03 |
| ACCU-CHEK COMFORT CURVE TEST STRIP (K982002) | Boehringer Mannheim Corp. | 1998-09-02 |
| ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 (K982501) | Alko Diagnostic Corp. | 1998-09-01 |
| ACCU-CHECK VOICEMATE (K982079) | Boehringer Mannheim Corp. | 1998-08-28 |
| AMY (K981653) | Abbott Laboratories | 1998-08-28 |
| ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE (K981897) | Roche Diagnostic Systems, Inc. | 1998-08-26 |
| CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY (K981931) | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-08-25 |
| CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 (K982845) | More Diagnostics | 1998-08-21 |
| HICHEM CHOLESTEROL REAGENT KIT (K982469) | Elan Pharma, Inc. | 1998-08-19 |
| SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (K982608) | Sangui Biotech, Inc. | 1998-08-19 |
| QUICK & SURE ONESTEP HOME PREGNANCY TEST (K981892) | Abacus Diagnostics | 1998-08-18 |
| OLYMPUS SERUM PROTEIN MULTICALIBRATOR, (K981854) | Olympus Diagnostica GmbH | 1998-08-18 |
| SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (K982251) | Sigma Diagnostics, Inc. | 1998-08-18 |
| PYRILINKS-D ASSAY KIT (K981364) | Metra Biosystems, Inc. | 1998-08-13 |
| PREALBUMIN CALIBRATOR (K982292) | Dade Behring, Inc. | 1998-08-13 |
| TUMOR MARKER CONTROL (K982473) | Diagnostic Products Corp. | 1998-08-12 |
| IMMULITE PSA CONTROL MODULE, MODEL LPSCM (K982637) | Diagnostic Products Corp. | 1998-08-12 |
| MICROALBUSTIX REAGENT STRIPS (K982219) | Bayer Corp. | 1998-08-12 |
| B2-MICROGLOBULIN CONTROL SET SERUM (K982471) | Boehringer Mannheim Corp. | 1998-08-06 |
| SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT (K982236) | Sigma Diagnostics, Inc. | 1998-08-05 |
| DADE TRU-LIQUID CARDIAC CONTROL (K982591) | Dade Behring, Inc. | 1998-08-05 |
| DIRECT LDL (K981303) | Abbott Laboratories | 1998-08-03 |
| DIRECT HDL (K981224) | Abbott Laboratories | 1998-08-03 |
| ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) (K981181) | Actimed Laboratories, Inc. | 1998-08-03 |
| UIBC (K982041) | Abbott Laboratories | 1998-07-30 |
| DIRECT HDL-CHOLESTROL LIQUID (K982341) | Randox Laboratories, Ltd. | 1998-07-30 |
| SENSOREX BLOOD GLUCOSE MONITORING SYSTEM (K980573) | Chronimed, Inc. | 1998-07-30 |
| HICHEM CALCIUM REAGENT KIT (K981794) | Hichem Diagnostics | 1998-07-29 |
| UREA (K981918) | Abbott Laboratories | 1998-07-28 |
| CARESIDE ANALYZER (K982118) | Exigent Diagnostics, Inc. | 1998-07-24 |
| AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR (K981978) | Pointe Scientific, Inc., | 1998-07-22 |
| TIBC (K981654) | Abbott Laboratories | 1998-07-22 |
| DBIL (K981943) | Abbott Laboratories | 1998-07-22 |
| MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) (K982277) | Nova Biomedical Corp. | 1998-07-22 |
| CREA (K981799) | Abbott Laboratories | 1998-07-22 |
| AMM (K981920) | Abbott Laboratories | 1998-07-22 |
| CHEM-CHEX STAT (NEW) (K982290) | Streck Laboratories, Inc. | 1998-07-22 |
| BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP (K981444) | Princeton BioMeditech Corp. | 1998-07-22 |
| MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 (K981493) | Polymer Technology Systems, Inc. | 1998-07-22 |
| ALBP (K981814) | Abbott Laboratories | 1998-07-22 |
| CARESIDE HDL-CHOLESTEROL (K981899) | Exigent Diagnostics, Inc. | 1998-07-14 |
| ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K982250) | Beckman Instruments, Inc. | 1998-07-14 |
| VIGIL PROTEIN CONTROL (K982224) | Beckman Coulter, Inc. | 1998-07-09 |
| AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 (K981706) | Abbott Laboratories | 1998-07-09 |
| ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 (K981883) | Boehringer Mannheim Corp. | 1998-07-07 |
| VIGIL HEMOGLOBIN (HBALC) CONTROLS (K982022) | Beckman Coulter, Inc. | 1998-07-06 |
| CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST (K981882) | Princeton BioMeditech Corp. | 1998-07-06 |
| URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 (K981933) | Medical Analysis Systems, Inc. | 1998-06-29 |
| AST/SGOT LIQUID REAGENT - KINETIC METHOD (K981650) | Teco Diagnostics | 1998-06-29 |
| AST (K981843) | Abbott Laboratories | 1998-06-29 |
| BIOSTRIDE FREE T4 EIA TEST KIT (K981243) | Biostride Diagnostics, Inc. | 1998-06-29 |
| I-STAT LACTATE TEST (K982071) | I-Stat Corp. | 1998-06-29 |
| HICHEM PHOSPHORUS REAGENT KIT (K981769) | Elan Pharma, Inc. | 1998-06-29 |
| CHOL (K981652) | Abbott Laboratories | 1998-06-29 |
| BIOSIGN HCG I - ONE STEP PREGNANCY TEST (K981443) | Princeton BioMeditech Corp. | 1998-06-25 |
| CARESIDE URIC ACID (K981604) | Careside, Inc. | 1998-06-25 |
| ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 (K981838) | Unotech Diagnostics, Inc. | 1998-06-25 |
| CARESIDE ANALYZER (K981610) | Careside, Inc. | 1998-06-25 |
| CHOL (K981476) | Abbott Laboratories | 1998-06-25 |
| CLEARPLAN EASY OVULATION TEST (K981271) | Unipath , Ltd. | 1998-06-25 |
| RAICHEM CO2 REAGENT (K982056) | Reagents Applications, Inc. | 1998-06-24 |
| OLYMPUS CALCIUM ARSENAZO III REAGENT (K982035) | Olympus Diagnostica GmbH | 1998-06-24 |
| CARESIDE TOTAL BILIRUBIN (K981588) | Careside, Inc. | 1998-06-23 |
| AMM (K981467) | Abbott Laboratories | 1998-06-22 |
| ALKP (K981806) | Abbott Laboratories | 1998-06-22 |
| URIC ACID (K981766) | Abbott Laboratories | 1998-06-19 |
| VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE (K981013) | Becton Dickinson Vacutainer Systems | 1998-06-17 |
| CA (K981578) | Abbott Laboratories | 1998-06-16 |
| PHOS (K981759) | Abbott Laboratories | 1998-06-16 |
| ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT (K981632) | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-06-15 |
| ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 (K981864) | Beckman Coulter, Inc. | 1998-06-12 |
| CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO (K981795) | Thermo Bioanalysis Corp. | 1998-06-12 |
| PHOS (K981118) | Abbott Laboratories | 1998-06-12 |
| ALBG (K981758) | Abbott Laboratories | 1998-06-12 |
| HDL (K981580) | Abbott Laboratories | 1998-06-11 |
| ACE T UPTAKE REAGENT TU CALIBRATORS (K981375) | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| ACE T4 REAGENT T4 CALIBRATORS (K981377) | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) (K981495) | Diagnostic Products Corp. | 1998-06-10 |
| URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER (K980047) | Yeongdong Pharmaceutical Corp. | 1998-06-10 |
| OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (K981743) | Olympus America, Inc. | 1998-06-09 |
| AMY (K981216) | Abbott Laboratories | 1998-06-08 |
| CO2 (K981840) | Abbott Laboratories | 1998-06-08 |
| IRON (K981581) | Abbott Laboratories | 1998-06-08 |
| DADE TRU-LIQUID CARDIAC CONTROL (K981622) | Dade Behring, Inc. | 1998-06-08 |
| RAPIDHCG PREGNANCY TEST (K981770) | Rapid Diagnostics, Inc. | 1998-06-05 |
| COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) (K980996) | Roche Diagnostic Systems, Inc. | 1998-06-05 |
| 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K981312) | Bayer Corp. | 1998-06-05 |