| BILIRUBIN-SL (TOTAL) ASSAY (K974874) | Diagnostic Chemicals, Ltd. (Usa) | 1998-02-12 |
| ABBOTT AXSYM SYSTEM (K974651) | Abbott Laboratories | 1998-02-12 |
| ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 (K980316) | Diagnostic Chemicals , Ltd. | 1998-02-12 |
| ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL (K974811) | Boston Biomedica, Inc. | 1998-02-10 |
| BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST (K973350) | Bio-Rad | 1998-02-09 |
| ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (K980130) | Radiometer America, Inc. | 1998-02-09 |
| DIGENE DML 2000 MICROPLATE LUMINOMETER (K980120) | Digene Corp. | 1998-02-06 |
| CARESIDE BUN (K980057) | Exigent Diagnostics, Inc. | 1998-02-05 |
| VACUTAINER BRAND PRONTO NEEDLES HOLDER (K980098) | Becton Dickinson Vacutainer Systems | 1998-02-05 |
| VACUETTE (MULTI-USE HOLDER) (K974873) | Greiner Meditech, Inc. | 1998-02-05 |
| EASYBLOOD GAS ANALYZER (K974526) | Medica Corp. | 1998-02-05 |
| ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT (K974839) | First Medical, Inc. | 1998-02-04 |
| AMYLASE (K980013) | Ac Biochemicals, Inc. | 1998-02-04 |
| T-UPTAKE MICROPLATE EIA (K980088) | Monobind | 1998-02-04 |
| CARESIDE TOTAL PROTEIN (K980042) | Exigent Diagnostics, Inc. | 1998-02-04 |
| ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (K973938) | Sfri, Inc. | 1998-02-04 |
| CARESIDE ALBUMIN (K980041) | Exigent Diagnostics, Inc. | 1998-02-04 |
| DBEST ONE-STEP OVULATION TEST (K974508) | Ameritek, Inc. | 1998-02-02 |
| RANDOX CALCIUM (K974607) | Randox Laboratories, Ltd. | 1998-02-02 |
| ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980028) | Trace America, Inc. | 1998-02-02 |
| AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (K974027) | Alfa Biotech (Uk) , Ltd. | 1998-02-02 |
| AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980030) | Trace America, Inc. | 1998-01-30 |
| PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 (K974858) | Diagnostic Chemicals , Ltd. | 1998-01-30 |
| BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS (K974825) | Boehringer Mannheim Corp. | 1998-01-30 |
| CARESIDE GLOBULIN (K980055) | Exigent Diagnostics, Inc. | 1998-01-28 |
| QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (K980135) | Radiometer America, Inc. | 1998-01-28 |
| STAT TRACKS (K974762) | Awareness Technology, Inc. | 1998-01-28 |
| VIROTROL III (K974613) | Blackhawk Biosystems, Inc. | 1998-01-27 |
| PYRILINKS-D ASSAY KIT (K974260) | Metra Biosystems, Inc. | 1998-01-26 |
| BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST (K974821) | Quidel Corp. | 1998-01-26 |
| QUICKSTICK PRO HCG TEST (K974615) | Phamatech | 1998-01-26 |
| ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K974451) | Lifescan, Inc. | 1998-01-26 |
| BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL (K974733) | Boehringer Mannheim Corp. | 1998-01-26 |
| SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST (K974851) | San Diego Biotech | 1998-01-22 |
| AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL (K974822) | Avl Scientific Corp. | 1998-01-22 |
| MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON (K972669) | Polymer Technology Systems, Inc. | 1998-01-22 |
| BM PRECIPATH(R) HDL/LDL-C CONTROL (K974826) | Boehringer Mannheim Corp. | 1998-01-22 |
| LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (K974859) | Diagnostic Chemicals , Ltd. | 1998-01-22 |
| ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (K974818) | Radiometer America, Inc. | 1998-01-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K974644) | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-01-13 |
| TRIAGE STATMETER (K973547) | Biosite Incorporated | 1998-01-13 |
| RANDOX INORGANIC PHOSPHOROUS (K974605) | Randox Laboratories, Ltd. | 1998-01-09 |
| TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE (K974827) | Biosite Incorporated | 1998-01-08 |
| OVULON MONITOR (K973860) | Conception Technology, Inc. | 1998-01-07 |
| TRACE REAGENT LINE FOR THE COBAS MIRA (K973869) | Trace America, Inc. | 1998-01-07 |
| RANDOX IRON (K974604) | Randox Laboratories, Ltd. | 1998-01-06 |
| REP CHOLESTEROL PROFILE CONTROL-II (K974609) | Helena Laboratories | 1998-01-06 |
| AIMSTICK PBD PREGNANCY (K974368) | Germaine Laboratories, Inc. | 1998-01-02 |
| AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (K974620) | Trace America, Inc. | 1998-01-02 |
| IMMULITE FREE T3 (K974634) | Diagnostic Products Corp. | 1998-01-02 |
| GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM (K971653) | Clinical Diagnostics, Inc. | 1998-01-02 |
| SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV (K974374) | Ohmeda Medical | 1998-01-02 |
| AIMSTICK PBD COMBO PREGNANCY (K974512) | Germaine Laboratories, Inc. | 1998-01-02 |
| SYSCOS IDC - G, IDC, BSC, IDC - G (K974262) | Scantibodies Laboratory, Inc. | 1997-12-24 |
| BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST (K974425) | Princeton BioMeditech Corp. | 1997-12-24 |
| OSOM HCG-URINE TEST MODEL 101 (K974159) | Wyntek Diagnostics, Inc. | 1997-12-24 |
| SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA (K974306) | Sangui Biotech, Inc. | 1997-12-23 |
| RDI HOMOGENEOUS HDL CHOLESTEROL TEST (K973988) | Reference Diagnostics, Inc. | 1997-12-22 |
| SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY (K974551) | Sealite Sciences, Inc. | 1997-12-22 |
| MIDSTREAM HOME REGNANCY TEST (K973825) | Germaine Laboratories, Inc. | 1997-12-19 |
| CHOICE ACCU-TEST PREGNANCY TEST KIT (K974154) | Sa Scientific, Inc. | 1997-12-19 |
| SIGNAL PREGNANCY TEST KIT (K974021) | Sa Scientific, Inc. | 1997-12-19 |
| QUICKVUE SEMI-Q HCG-COMBO (K974052) | Quidel Corp. | 1997-12-19 |
| MICROPROTEIN STANDARD KIT (K974290) | Verichem Laboratories, Inc. | 1997-12-19 |
| COBAS INTEGRA HDL-CHOLESTEROL DIRECT (K973284) | Roche Diagnostic Systems, Inc. | 1997-12-18 |
| IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE (K974396) | Diametrics Medical, Inc. | 1997-12-18 |
| ELECSYS CK-MB STAT (K974421) | Boehringer Mannheim Corp. | 1997-12-17 |
| LACTEST I (K971944) | Jwt, Inc. | 1997-12-17 |
| IL TEST UREA NITROGEN (K974337) | Instrumentation Laboratory CO | 1997-12-17 |
| DBEST ONE-STEP HCG SERUM/URINE TEST (K973957) | Ameritek, Inc. | 1997-12-17 |
| IL TEST AMYLASE (K974125) | Instrumentation Laboratory CO | 1997-12-17 |
| VIGIL LIPID CONTROL (K974452) | Beckman Instruments, Inc. | 1997-12-17 |
| PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH (K973676) | Sorrento Biochemical, Inc. | 1997-12-16 |
| ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK (K972473) | Lifescan, Inc. | 1997-12-16 |
| ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM (K974322) | Europa Scientific, Ltd. | 1997-12-16 |
| ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH (K973678) | Sorrento Biochemical, Inc. | 1997-12-15 |
| BECKMAN CALIBRATOR 2 (CAL2) (K973932) | Beckman Instruments, Inc. | 1997-12-15 |
| ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS (K973662) | Boehringer Mannheim Corp. | 1997-12-15 |
| DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH (K973677) | Sorrento Biochemical, Inc. | 1997-12-15 |
| URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (K970277) | Astoria-Pacific, Inc. | 1997-12-11 |
| TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL (K974461) | Biosite Incorporated | 1997-12-10 |
| ELECSYS CALCHECK VITAMIN B12 (K974383) | Boehringer Mannheim Corp. | 1997-12-08 |
| AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 (K974053) | Diagnostic Chemicals , Ltd. | 1997-12-08 |
| ELECSYS CALCHECK FOLATE (K974384) | Boehringer Mannheim Corp. | 1997-12-08 |
| TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K973616) | Bayer Corp. | 1997-12-05 |
| ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (K974003) | Diagnostic Chemicals , Ltd. | 1997-12-05 |
| ACCUWELL PHENYLALANINE ASSAY (K974047) | Neometrics, Inc. | 1997-12-05 |
| SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (K973742) | Sendx Medical, Inc. | 1997-12-03 |
| BECKMAN URINE PROTEIN CALIBRATOR (UCAL) (K973928) | Beckman Instruments, Inc. | 1997-12-01 |
| QUICKVUE ONE-STEP HCG-COMBO (K973841) | Quidel Corp. | 1997-12-01 |
| SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) (K974108) | Quidel Corp. | 1997-11-26 |
| CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO (K973858) | Quidel Corp. | 1997-11-26 |
| ABBOTT AXSYM TROPONIN-I (K974103) | Abbott Laboratories | 1997-11-25 |
| UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 (K973931) | Diagnostic Chemicals , Ltd. | 1997-11-24 |
| 17 B-ESTRADIOL (ELISA) (K973901) | Kmi Diagnostics, Inc. | 1997-11-24 |
| ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) (K973369) | Roche Diagnostic Systems, Inc. | 1997-11-21 |
| AUTODELFIA NEONATAL HTSH L KIT (B077-112) (K973276) | Eg &G Wallac | 1997-11-20 |
| PROGESTERONE ELISA (K973898) | Kmi Diagnostics, Inc. | 1997-11-13 |
| DHEA-S (K973897) | Kmi Diagnostics, Inc. | 1997-11-13 |
| ELECSYS VITAMIN B12 ASSAY (K973702) | Boehringer Mannheim Corp. | 1997-11-13 |