| ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 (K010429) | Beckman Coulter, Inc. | 2001-06-05 |
| CHEMWELL, MODEL 2900 (K010877) | Awareness Technology, Inc. | 2001-05-23 |
| ANALYST PANELS + ANALYTICAL TEST ROTOR (K010864) | Hemagen Diagnostics, Inc. | 2001-05-21 |
| MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 (K011233) | Apex BioTechnology Corp. | 2001-05-18 |
| HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 (K011169) | International Enzymes, Inc. | 2001-05-18 |
| N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 (K003609) | Osteometer Biotech A/S | 2001-05-16 |
| MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (K011213) | Beckman Coulter, Inc. | 2001-05-16 |
| BECKMAN COULTER DNASE B CALIBRATOR (K010696) | Beckman Coulter, Inc. | 2001-05-10 |
| GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS (K010520) | Instrumentation Laboratory CO | 2001-05-07 |
| ATLAST DATA MANAGEMENT SOFTWARE (DMS) (K010605) | Amira Medical, Inc. | 2001-05-07 |
| RAICHEM CREATININE URINE STANDARD (K011126) | Hemagen Diagnostics, Inc. | 2001-05-02 |
| SURE CHECK OVULATION PREDICTOR (K010244) | Chembio Diagnostic Systems, Inc. | 2001-05-02 |
| TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 (K004038) | Scantibodies Laboratory, Inc. | 2001-04-30 |
| PICCOLO CHLORIDE TEST SYSTEM (K010670) | Abaxis, Inc. | 2001-04-26 |
| URS-1K (KETONE TESST) (K003987) | Teco Diagnostics | 2001-04-26 |
| ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS (K004010) | Roche Diagnostics Corp. | 2001-04-26 |
| DIMENSION CTNI CALIBRATOR (K010314) | Dade Behring, Inc. | 2001-04-20 |
| DIMENSION CTNI FLEX REAGENT CARTRIDGE (K010313) | Dade Behring, Inc. | 2001-04-20 |
| WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 (K010421) | Wiener Laboratories Saic | 2001-04-13 |
| VIGIL DNASE B CONTROL (K010693) | Beckman Coulter, Inc. | 2001-04-11 |
| ATAC PAK AST REAGENT KIT (K010488) | Elan Holdings, Inc. | 2001-04-09 |
| MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (K010328) | Izon Business Products, Inc. | 2001-04-09 |
| SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT (K010593) | Sa Scientific, Inc. | 2001-04-05 |
| SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (K010652) | Sigma Diagnostics, Inc. | 2001-03-30 |
| BAYER ADVIA IMS SYSTEM (K010201) | Bayer Corp. | 2001-03-29 |
| PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 (K010403) | Home Diagnostics, Inc. | 2001-03-26 |
| JAS MAGNESIUM REAGENT (K003835) | Jas Diagnostics, Inc. | 2001-03-23 |
| BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) (K003752) | Biosafe Laboratories, Inc. | 2001-03-23 |
| RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (K010052) | Respironics, Inc. | 2001-03-19 |
| ACCU-CHEK INFORM METER (K003846) | Roche Diagnostics Corp. | 2001-03-19 |
| NEOLYNX SCREENING APPLICATION MANAGER (K003584) | Micromass, Inc. | 2001-03-19 |
| DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 (K010206) | Dade Behring, Inc. | 2001-03-16 |
| TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 (K010266) | Biosite Incorporated | 2001-03-16 |
| RANDOX GLUCOSE (GOD/PAP) (K003346) | Randox Laboratories, Ltd. | 2001-03-15 |
| N PROTEIN STANDARD UY CALIBRATOR (K003501) | Dade Behring, Inc. | 2001-03-15 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND (K010061) | Dade Behring, Inc. | 2001-03-14 |
| ALPHA DX SYSTEM (K010562) | First Medical, Inc. | 2001-03-13 |
| N LATEX CYSTATIN C (K003503) | Dade Behring, Inc. | 2001-03-13 |
| ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 (K010428) | Beckman Coulter, Inc. | 2001-03-13 |
| ACCU-CHEK COMFORT CURVE TEST STRIP (K010362) | Roche Diagnostics Corp. | 2001-03-07 |
| VIGIL SEROLOGY CONTROL LEVEL C (K010358) | Beckman Coulter, Inc. | 2001-03-05 |
| ELECSYS TESTOSTERONE CALSET II (K003411) | Roche Diagnostics Corp. | 2001-03-01 |
| CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK (K010111) | Medical Analysis Systems, Inc. | 2001-02-28 |
| PHOSPHORUS REAGENT (K003912) | Jas Diagnostics, Inc. | 2001-02-21 |
| EZ-HCG URINE(PREGNANCY TEST) (K003856) | Biomerica, Inc. | 2001-02-21 |
| DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 (K010208) | Dade Behring, Inc. | 2001-02-20 |
| TOTAL BILIRUBIN REAGENT (K003892) | Intersect Systems, Inc. | 2001-02-20 |
| IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) (K004002) | Diagnostic Products Corp. | 2001-02-14 |
| DELFIA NEONATAL IRT KIT, MODEL A005-110 (K003664) | Wallac OY | 2001-02-14 |
| ELECSYS HCG+B CALCHECK (K010237) | Roche Diagnostics Corp. | 2001-02-14 |
| LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR (K010030) | Synergent Biochem Inc.-Clinical Controls Div. | 2001-02-14 |
| AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 (K003668) | Wallac OY | 2001-02-12 |
| TOTAL BILIRUBIN (K003829) | Jas Diagnostics, Inc. | 2001-02-12 |
| ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY (K010050) | Bayer Diagnostics Corp. | 2001-02-05 |
| IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 (K003597) | Diagnostic Products Corp. | 2001-02-05 |
| EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER (K002407) | Medica Corp. | 2001-02-02 |
| PERSONAL GLUCOSE CONTROL CHARTING SYSTEM (K002688) | Lxn Corp. | 2001-02-01 |
| DIRECT BILIRUBIN (K003693) | Jas Diagnostics, Inc. | 2001-01-29 |
| ELECSYS FSH CALSET II (K003409) | Roche Diagnostics Corp. | 2001-01-26 |
| STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD (K003696) | Dade Behring, Inc. | 2001-01-25 |
| ELECSYS HCG STAT CLASET II (K003941) | Roche Diagnostics Corp. | 2001-01-25 |
| GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM (K002621) | Apex BioTechnology Corp. | 2001-01-22 |
| GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM (K002624) | Apex BioTechnology Corp. | 2001-01-22 |
| FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (K002638) | Future Diagnostics B.V. | 2001-01-17 |
| ELECSYS DHEA-S (K003174) | Roche Diagnostics Corp. | 2001-01-17 |
| CA 125 II CALCHECK (K003967) | Roche Diagnostics Corp. | 2001-01-12 |
| GENUA MENOPAUSE MONITOR TEST KIT (K002450) | Genua 1944, Inc. | 2001-01-12 |
| ELECSYS CA 125 II CALSET (K003969) | Roche Diagnostics Corp. | 2001-01-12 |
| EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION (K003257) | Cybercare Technologies, Inc. | 2000-12-22 |
| SYNCHRON SYSTEMS AMMONIA REAGENT (K003196) | Beckman Coulter, Inc. | 2000-12-22 |
| CONFORMANCE CHEMISTRY CONTROL C3 (K003716) | Consolidated Technology | 2000-12-20 |
| ELECSYS DHEA-S CALCHECK (K003772) | Roche Diagnostics Corp. | 2000-12-20 |
| APPRAISE URINE MICROALBUMIN COLLECTION KIT (K002156) | Osborn Group, Inc. | 2000-12-19 |
| BAYER RAPIDPOINT 400 SYSTEM (K002738) | Bayer Corp. | 2000-12-19 |
| ROCHE DIAGNOSTICS CK-MB (K003158) | Roche Diagnostics Corp. | 2000-12-18 |
| MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER (K003721) | Olympus America, Inc. | 2000-12-18 |
| SATURN BLOOD GLUCOSE MONITORING TEST STRIP (K001441) | Lifescan, Inc. | 2000-12-18 |
| ELECSYS HCG AND BETA TEST SYSTEM (K003178) | Roche Diagnostics Corp. | 2000-12-14 |
| CREATININE (K003247) | Jas Diagnostics, Inc. | 2000-12-14 |
| FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 (K000582) | Abbott Diabetes Care, Inc. | 2000-12-05 |
| ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (K002128) | Diagnostic Systems Laboratories, Inc. | 2000-12-05 |
| ALBUMIN (K003327) | Jas Diagnostics, Inc. | 2000-12-05 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (K003242) | Bio-Rad | 2000-11-30 |
| FASTPACK CALIBRATORS (K003096) | Qualigen, Inc. | 2000-11-30 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (K003239) | Bio-Rad | 2000-11-30 |
| FASTPACK CONTROL (K003095) | Qualigen, Inc. | 2000-11-29 |
| SYNCHRON CONTROL (K003488) | Beckman Coulter, Inc. | 2000-11-27 |
| ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 (K003093) | Diagnostic Chemicals , Ltd. | 2000-11-27 |
| N/T PROTEIN CONTROL SL (K002852) | Dade Behring, Inc. | 2000-11-27 |
| BIO-RAD %CDT TIA (K001651) | Axis-Shield Biochemicals, Asa | 2000-11-22 |
| MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K002199) | Pointe Scientific, Inc., | 2000-11-20 |
| TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (DEN000010) | Biosite Incorporated | 2000-11-20 |
| ACCESS ULTRASENSITIVE HGH CALIBRATORS (K003098) | Beckman Coulter, Inc. | 2000-11-20 |
| CREATININE PLUS (K003261) | Roche Diagnostics Corp. | 2000-11-16 |
| SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS (K001993) | Abbott Laboratories | 2000-11-13 |
| QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 (K001249) | Consolidated Technologies of Wisconsin | 2000-11-02 |
| ACCUWELL TSH, MODEL KAW-TSH-960 (K001455) | Neometrics, Inc. | 2000-11-02 |
| MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 (K002456) | Becton Dickinson Vacutainer Systems | 2000-11-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K003112) | Ortho-Clinical Diagnostics, Inc. | 2000-11-02 |
| OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER (K002982) | Olympus America, Inc. | 2000-10-25 |