| SMARTPREP CENTRIFUGE SYSTEM (K991430) | Harvest Technologies, LLC | 1999-05-28 |
| VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE (K991088) | Becton Dickinson Vacutainer Systems | 1999-05-28 |
| INSURE PREGNANCY TEST (K991515) | Inbios Intl., Inc. | 1999-05-28 |
| MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI (K991299) | Princeton BioMeditech Corp. | 1999-05-28 |
| MODIFICATION TO ALCYON DIRECT BILIRUBIN (K991175) | Abbott Laboratories | 1999-05-28 |
| MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (K990247) | Polymer Technology Systems, Inc. | 1999-05-28 |
| GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM (K991156) | Great Smokies Diagnostic Laboratory | 1999-05-28 |
| CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 (K991108) | A.P. Total Care, Inc. | 1999-05-25 |
| TOTAL IRON, MODELS FE 109-01, FE 109-02 (K991244) | A.P. Total Care, Inc. | 1999-05-25 |
| EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) (K991466) | Selfcare, Inc. | 1999-05-25 |
| GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 (K990981) | A.P. Total Care, Inc. | 1999-05-25 |
| EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) (K991386) | Selfcare, Inc. | 1999-05-25 |
| BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 (K991111) | A.P. Total Care, Inc. | 1999-05-25 |
| ALBUMIN BCG, MODEL AL 103-01 (K990978) | A.P. Total Care, Inc. | 1999-05-25 |
| CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 (K991109) | A.P. Total Care, Inc. | 1999-05-25 |
| BUN, MODEL BU 104-01 (K990980) | A.P. Total Care, Inc. | 1999-05-25 |
| URIC ACID, MODEL UA112-01 (K991247) | A.P. Total Care, Inc. | 1999-05-25 |
| BAYER ADVIA 1650 CHEMISTRY SYSTEM (K990346) | Bayer Corp. | 1999-05-21 |
| SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K984261) | Lifescan, Inc. | 1999-05-21 |
| VACUTAINER BRAND CTAD TUBE (MULTIPLE) (K991120) | Becton Dickinson Vacutainer Systems | 1999-05-19 |
| ELAN ALKALINE PHOSPHATE REAGENT KIT (K991387) | Elan Holdings, Inc. | 1999-05-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS (K990016) | Ortho-Clinical Diagnostics, Inc. | 1999-05-19 |
| ACP (K991010) | Abbott Diagnostics Mfg., Inc. | 1999-05-19 |
| MODIFICATION OF N/T PROTEIN CONTROL SL (K991182) | Dade Behring, Inc. | 1999-05-19 |
| AIA-PACK FT3 ASSAY (K991252) | Tosoh Medics, Inc. | 1999-05-11 |
| CALCITONIN (K990073) | Kmi Diagnostics, Inc. | 1999-05-11 |
| ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY (K991369) | Germaine Laboratories, Inc. | 1999-05-10 |
| SAS ONE-STEP PREGNANCY (K990741) | Sa Scientific, Inc. | 1999-05-10 |
| ATLAST GLUCOSE CONTROL SOLUTION (K991075) | Amira Medical, Inc. | 1999-05-10 |
| MODIFICATION OF SAS SERUM/URINE HCG (K990684) | Sa Scientific, Inc. | 1999-05-10 |
| SAS HCG-CHECK (K991193) | Sa Scientific, Inc. | 1999-05-04 |
| IN TOUCH DIABETES MANAGEMENT SOFTWARE (K984527) | Lifescan, Inc. | 1999-04-29 |
| QUICKCARD HCG COMBO TEST, MODEL #9014 (K991095) | Phamatech | 1999-04-28 |
| MODIFICATION OF: DAVIDSTRIP HCG (K991067) | Simex Medical, Inc. | 1999-04-27 |
| EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (K990971) | Medica Corp. | 1999-04-27 |
| ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 (K990610) | Bio-Rad | 1999-04-27 |
| FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K990939) | Selfcare, Inc. | 1999-04-20 |
| CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 (K990754) | Diagnostic Chemicals , Ltd. | 1999-04-20 |
| CARESIDE CK (K990439) | Careside, Inc. | 1999-04-19 |
| CARESIDE CKMB (K990434) | Careside, Inc. | 1999-04-19 |
| REVISED C-REACTIVE PROTEIN CALIBRATOR (K990824) | Dade Behring, Inc. | 1999-04-16 |
| MICROPLATE NEONATAL GALT ASSAY (K990827) | Bio-Rad | 1999-04-09 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS (K990984) | Ortho-Clinical Diagnostics, Inc. | 1999-04-08 |
| MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 (K990888) | Bio-Rad | 1999-04-07 |
| CLEARPLAN EASY HOME PREGNANCY TEST (K990262) | Unipath , Ltd. | 1999-04-07 |
| ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 (K990424) | Bio-Rad | 1999-03-31 |
| ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 (K990608) | Bio-Rad | 1999-03-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS (K990783) | Ortho-Clinical Diagnostics, Inc. | 1999-03-25 |
| RANDOX ALBUMIN (K984494) | Randox Laboratories, Ltd. | 1999-03-23 |
| ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 (K990393) | Bio-Rad | 1999-03-22 |
| DIMENSION SPECIAL PROTEIN CALIBRATOR (K990554) | Dade Behring, Inc. | 1999-03-22 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) (K990460) | Roche Diagnostics Corp. | 1999-03-22 |
| OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 (K990249) | Phamatech | 1999-03-22 |
| SAS HCG SERUM CONTROLS (K990720) | Sa Scientific, Inc. | 1999-03-19 |
| SAS HCG URINE CONTROLS (K990755) | Sa Scientific, Inc. | 1999-03-19 |
| ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 (K990317) | Bio-Rad | 1999-03-18 |
| CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 (K990036) | Careside, Inc. | 1999-03-18 |
| GLUCOMETER ELITE XL BLOOD GLUCOSE METER (K984006) | Bayer Corp. | 1999-03-18 |
| ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 (K990394) | Bio-Rad | 1999-03-18 |
| CARESIDE AST (K990009) | Careside, Inc. | 1999-03-16 |
| ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 (K990391) | Bio-Rad | 1999-03-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS (K990531) | Ortho-Clinical Diagnostics, Inc. | 1999-03-12 |
| OSOM CARD II HCG-URINE TEST, MODEL 102 (K990578) | Wyntek Diagnostics, Inc. | 1999-03-09 |
| ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 (K990282) | Bio-Rad | 1999-03-09 |
| OSOM CARD PREGNANCY TEST, MODEL 103 (K990576) | Wyntek Diagnostics, Inc. | 1999-03-09 |
| BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K983071) | Respironics, Inc. | 1999-03-04 |
| MTM BIOSCANNER K TEST STRIPS (K981865) | Polymer Technology Systems, Inc. | 1999-02-26 |
| IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 (K990222) | Diagnostic Products Corp. | 1999-02-26 |
| MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (K990223) | Unipath , Ltd. | 1999-02-24 |
| FACT PLUS ONE STEP PREGNANCY TEST (K990373) | Abbott Laboratories | 1999-02-22 |
| INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST (K984079) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST (K984080) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| INSTANT-VIEW PREGNANCY COMBO TEST (K984077) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| INSTANT-VIEW PREGNANCY URINE TEST (K984076) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST (K984075) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| MAGNETIC TIBC KIT (K990216) | Reference Diagnostics, Inc. | 1999-02-16 |
| CK (K983070) | Abbott Laboratories | 1999-02-16 |
| QUANTASE PHE/GAL SCREENING ASSAY (K984463) | Quantase , Ltd. | 1999-02-16 |
| DS30 HCY HOMOCYSTEINE ASSAY KIT (K982003) | Drew Scientific , Ltd. | 1999-02-11 |
| INFINITY GLUCOSE REAGENT (K984574) | Sigma Diagnostics, Inc. | 1999-02-11 |
| CARESIDE AMYLASE (K990025) | Careside, Inc. | 1999-02-08 |
| ACCU-CHEK HQ SYSTEM (K983047) | Boehringer Mannheim Corp. | 1999-02-05 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 (K984520) | Nichols Institute Diagnostics | 1999-02-05 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 (K984166) | Ortho-Clinical Diagnostics, Inc. | 1999-02-05 |
| ABBOTT ARCHITECT FOLATE (K984301) | Abbott Laboratories | 1999-02-05 |
| ABBOTT ARCHITECT B12 (K984108) | Abbott Laboratories | 1999-02-03 |
| OPTICOAT T4 EIA KIT (K982298) | Biotecx Laboratories, Inc. | 1999-02-03 |
| WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 (K982307) | Wallac, Inc. | 1999-02-02 |
| ELECSYS IGE CALCHECK (K984419) | Boehringer Mannheim Corp. | 1999-02-02 |
| ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 (K984625) | Bio-Rad | 1999-02-02 |
| ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 (K984604) | Bio-Rad | 1999-02-02 |
| OSTEOMARK NTX SERUM EIA (K983457) | Ostex Intl., Inc. | 1999-02-02 |
| LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 (K984594) | Bio-Rad | 1999-02-02 |
| QUANTEX ASO-CRP-RP CONTROL II (K984437) | Instrumentation Laboratory CO | 1999-02-02 |
| AVL OMNI MODULAR ANALYZER (K990092) | Avl Scientific Corp. | 1999-01-29 |
| LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 (K984477) | Bio-Rad | 1999-01-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K990026) | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 |
| ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 (K984626) | Bio-Rad | 1999-01-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS (K983674) | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 |
| SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT (K984402) | Beckman Coulter, Inc. | 1999-01-29 |