| ELECSYS B-CROSSLAPS CALCHECK (K000042) | Roche Diagnostics Corp. | 2000-03-17 |
| ELECSYS CORTISOL TEST SYSTEM (K000270) | Roche Diagnostics Corp. | 2000-03-07 |
| UBAS (K993941) | Marukin Diagnostics | 2000-03-02 |
| TRIAGE BNP CALIBRATION VERIFICATION CONTROLS (K000231) | Biosite Incorporated | 2000-03-02 |
| DIMENSION SPECIAL PROTEIN CALIBRATOR (K994291) | Dade Behring, Inc. | 2000-03-01 |
| TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS (K000230) | Biosite Incorporated | 2000-02-29 |
| BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K000318) | Bionostics, Inc. | 2000-02-28 |
| BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS (K000056) | Biocell Laboratories, Inc. | 2000-02-24 |
| ACCU-CHEK COMPLETE METER (K000364) | Roche Diagnostics Corp. | 2000-02-23 |
| IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 (K000257) | Diagnostic Products Corp. | 2000-02-23 |
| ACCU-CHEK ADVANTAGE METER (K000365) | Roche Diagnostics Corp. | 2000-02-23 |
| CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 (K000055) | Diagnostic Chemicals , Ltd. | 2000-02-18 |
| WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 (DEN990008) | Wallac, Inc. | 2000-02-15 |
| 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K992662) | Bayer Corp. | 2000-02-15 |
| QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 (K000116) | Consolidated Technologies, Inc. | 2000-02-15 |
| SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR (K000331) | Beckman Coulter, Inc. | 2000-02-10 |
| GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 (K000102) | Teco Diagnostics | 2000-02-08 |
| BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K994438) | Spectrx, Inc. | 2000-02-04 |
| ADVANTAGE HCG TEST (URINE/SERUM) (K994227) | Advantage Diagnostics Corp. | 2000-02-03 |
| SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR (K994168) | Beckman Coulter, Inc. | 2000-02-03 |
| SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR (K994169) | Beckman Coulter, Inc. | 2000-02-03 |
| IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (K994035) | Diagnostic Chemicals , Ltd. | 2000-02-01 |
| 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM (K994148) | Implant Innovations, Inc. | 2000-02-01 |
| ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (K994346) | Sendx Medical, Inc. | 2000-02-01 |
| TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (K994115) | Dade Behring, Inc. | 2000-01-28 |
| IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 (K994085) | Diagnostic Products Corp. | 2000-01-28 |
| GAMBRO DQM 200 (K990039) | Gambro Healthcare | 2000-01-27 |
| ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H (K000067) | Teco Diagnostics | 2000-01-20 |
| ACON ONE STEP HOME PREGNANCY TEST STRIP (K993483) | ACON Laboratories, Inc. | 2000-01-20 |
| DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR (K994114) | Dade Behring, Inc. | 2000-01-20 |
| OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 (K994189) | Olympus Diagnostica GmbH | 2000-01-20 |
| ACCESS HYBRITECH PSA QC, MODEL 37209 (K994200) | Beckman Coulter, Inc. | 2000-01-18 |
| FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM (K992684) | Abbott Diabetes Care, Inc. | 2000-01-14 |
| ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 (K994439) | Beckman Coulter, Inc. | 2000-01-14 |
| ACCESS OSTASE QC (K994277) | Beckman Coulter, Inc. | 2000-01-14 |
| MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) (K993377) | Polymer Technology Systems, Inc. | 2000-01-13 |
| SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR (K994325) | Beckman Coulter, Inc. | 2000-01-12 |
| ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (K992859) | Radiometer America, Inc. | 2000-01-10 |
| CLINICAL BLOOD GAS MIXTURE (K993789) | General Air Service and Supply | 2000-01-10 |
| ACCESS HYBRITECH FREE PSA QC, MODEL 37219 (K993210) | Beckman Coulter, Inc. | 2000-01-05 |
| URINALYSIS REAGENT STRIPS (10 PARAMETERS) (K993850) | International Newtech Development, Inc. | 2000-01-03 |
| HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT (K992148) | Morax | 1999-12-29 |
| MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 (K983860) | Polymer Technology Systems, Inc. | 1999-12-27 |
| K-ASSAY MULTI-ANALYTE CALIBRATOR (K993853) | Kamiya Biomedical Co. | 1999-12-27 |
| CARESIDE DIRECT BILIRUBIN (K993771) | Careside, Inc. | 1999-12-27 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS (K994145) | Ortho-Clinical Diagnostics, Inc. | 1999-12-22 |
| AXIS %CDT TURBIDIMETRIC IMMUNOASSAY (K992502) | Axis | 1999-12-21 |
| FIRST RESPONSE 1-STEP PREGNANCY (K992232) | Armkel, LLC | 1999-12-21 |
| QUANTECH TOTAL B-HCG ASSAY (K990258) | Quantech , Ltd. | 1999-12-21 |
| BIO-RAD HOMOCYSTEINE BY HPLC (K993107) | Bio-Rad | 1999-12-21 |
| TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION (K981915) | The Binding Site, Ltd. | 1999-12-20 |
| PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR (K993096) | Lifestream Technologies, Inc. | 1999-12-20 |
| CLEARPLAN EASY II HOME PREGNANCY TEST (K993333) | Unipath , Ltd. | 1999-12-16 |
| WAKO L-TYPE GOT TEST (K993468) | Wako Chemicals USA, Inc. | 1999-12-16 |
| AVL OPTI CRITICAL CARE ANALYZER (K993837) | Avl Scientific Corp. | 1999-12-16 |
| BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 (K993571) | Bayer Corp. | 1999-12-16 |
| ACCU-CHEK SIMPLICITY SYSTEM (K993829) | Roche Diagnostics Corp. | 1999-12-09 |
| QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 (K993631) | Seracare Technology | 1999-12-09 |
| QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 (K992939) | Seracare Technology | 1999-12-09 |
| TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) (K993353) | Bayer Corp. | 1999-12-06 |
| BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY (K993309) | Bayer Corp. | 1999-12-06 |
| CARESIDE ANALYZER (K993634) | Careside, Inc. | 1999-12-02 |
| CLEARVIEW EASY HCG PREGNANCY TEST (K993703) | Unipath , Ltd. | 1999-12-02 |
| ACON ONE STEP PREGNANCY TEST STRIP (URINE) (K993203) | ACON Laboratories, Inc. | 1999-12-01 |
| ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) (K993317) | ACON Laboratories, Inc. | 1999-12-01 |
| TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 (K993546) | Medical Analysis Systems, Inc. | 1999-11-30 |
| ELECSYS PARATHYROID HORMONE CALCHECK (K993642) | Roche Diagnostics Corp. | 1999-11-30 |
| APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH (K993310) | Dade Behring, Inc. | 1999-11-30 |
| HICHEM ISE ELECTROLYTE REFERENCE (K992842) | Elan Holdings, Inc. | 1999-11-26 |
| SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS (K993023) | Beckman Coulter, Inc. | 1999-11-26 |
| MODIFICATION TO DOCUMENT THYROID CAL.VER (K993014) | Casco-Nerl Diagnostics Corporation (Maine) | 1999-11-26 |
| TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION (K981914) | The Binding Site, Ltd. | 1999-11-26 |
| HICHEM ISE ELECTROLYTE BUFFER (K992844) | Elan Holdings, Inc. | 1999-11-26 |
| K-ASSAY APO A1/B CALIBRATOR SET (K993606) | Kamiya Biomedical Co. | 1999-11-26 |
| NEW MULTIPLES REAGENT STRIPS (K992257) | Bayer Corp. | 1999-11-24 |
| PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K993360) | Roche Diagnostics Corp. | 1999-11-24 |
| ABL 735 ANALYZER (K991417) | Radiometer America, Inc. | 1999-11-24 |
| ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK (K992710) | Abbott Laboratories | 1999-11-24 |
| PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K992900) | Roche Diagnostics Corp. | 1999-11-24 |
| GEM PREMIER 3000 (K992834) | Instrumentation Laboratory CO | 1999-11-24 |
| HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] (K993128) | Health Hero Network, Inc. | 1999-11-23 |
| CARDIASURE CARDIAC MARKERS CONTROL (K993723) | Quantimetrix Corp. | 1999-11-23 |
| ONE-STEP DOUBLE-CHEK PREGNANCY TEST (K992915) | Biomedical Products Corp. | 1999-11-18 |
| IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 (K993251) | Diagnostic Products Corp. | 1999-11-17 |
| QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (K993715) | Seracare Technology | 1999-11-16 |
| QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 (K992770) | Seracare Technology | 1999-11-12 |
| IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 (K993254) | Diagnostic Products Corp. | 1999-11-12 |
| FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K993632) | Selfcare, Inc. | 1999-11-12 |
| MICROALBUSTIX REAGENT STRIPS (OTC) (K991315) | Bayer Corp. | 1999-11-12 |
| BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) (K992136) | Bayer Corp. | 1999-11-09 |
| LYPHOCHEK ANEMIA CONTROL, MODEL 500 (K992741) | Bio-Rad | 1999-11-09 |
| WAKO BILIRUBIN CALIBRATOR (K993219) | Wako Chemicals USA, Inc. | 1999-11-09 |
| WAKO L-TYPE TRIGLYCERIDE TEST (K993466) | Wako Chemicals USA, Inc. | 1999-11-09 |
| OSTEOMARK NTX POC (K992997) | Metrika, Inc. | 1999-11-09 |
| WAKO L-TYPE UA F TEST (K993469) | Wako Chemicals USA, Inc. | 1999-11-09 |
| AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 (K993141) | Phamatech | 1999-11-08 |
| BIO-RAD CODA NEONATAL GALT ASSAY (K993536) | Bio-Rad | 1999-11-04 |
| QUANTECH CK-MB ASSAY (K984433) | Quantech , Ltd. | 1999-11-01 |
| PICCOLO SODIUM TEST SYSTEM (K993211) | Abaxis, Inc. | 1999-10-25 |
| ABBOTT AXSYM HOMOCYSTEINE (K992858) | Abbott Laboratories | 1999-10-25 |