| GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM (K061234) | Glucoplus, Inc. | 2006-10-30 |
| CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 (K062916) | Cliniqa Corporation | 2006-10-23 |
| INNOVACON HCG UKTRA TEST DEVICE (K062361) | Innovacon, Inc. | 2006-10-23 |
| AMNIOSTAT-FLM-PG (K061549) | Irvine Scientific Sales Co., Inc. | 2006-10-18 |
| ABL8X7 FLEX (K051968) | Radiometer Medical Aps | 2006-10-16 |
| AUDIT MICROCV IMMUNOASSAY LINEARITY SET (K062668) | Aalto Scientific, Ltd. | 2006-10-16 |
| LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT (K062808) | Catch Incorporated | 2006-10-13 |
| PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS (K062972) | Roche Diagnostics Corp. | 2006-10-13 |
| DIACHEX BLOOD GLUCOSE MONITORING SYSTEM (K062829) | Tyson Bioresearch, Inc. | 2006-10-10 |
| OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (K061575) | Olympus America, Inc. | 2006-10-05 |
| DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL (K062035) | Dade Behring, Inc. | 2006-10-04 |
| MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (K062751) | Quantimetrix Corp. | 2006-10-03 |
| ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP (K062180) | Horiba Abx | 2006-10-02 |
| VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 (K062501) | Maine Standards Co. | 2006-09-29 |
| EPOC BLOOD ANALYSIS SYSTEM (K061597) | Epocal, Inc. | 2006-09-27 |
| DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 (K062334) | Dade Behring, Inc. | 2006-09-22 |
| ARCHITECT CORTISOL ASSAY (K062204) | Seradyn, Inc. | 2006-09-22 |
| SELFCHECK GLUCO (K061528) | Card Guard Scientific Survival , Ltd. | 2006-09-22 |
| HEMOSIL HOMOCYSTEINE AND CONTROLS (K061598) | Instrumentation Laboratory CO | 2006-09-22 |
| MODIFICATION TO MYALLERGY TEST (K061979) | Immunetech Corporation | 2006-09-22 |
| EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST (K062235) | Taidoc Technology Corporation | 2006-09-19 |
| EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 (K061992) | Eps Bio Technology Corp. | 2006-09-19 |
| GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT (K061974) | Instrumentation Laboratory CO | 2006-09-15 |
| ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 (K061190) | Beckman Coulter, Inc. | 2006-09-15 |
| PREVU POINT OF CARE SKIN STEROL TEST (K062092) | Premd, Inc. | 2006-09-15 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 (K062319) | Roche Diagnostics Corp. | 2006-09-13 |
| DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061795) | Dade Behring, Inc. | 2006-09-11 |
| ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 (K062058) | Bayer Healthcare | 2006-09-11 |
| GLUCOSE HK NEW FORMULATION TEST SYSTEM (K062239) | Roche Diagnostics Corp. | 2006-09-11 |
| URYXXON RELAX URINE ANALYZER (K061742) | Macherey-Nagel GmbH & Co. KG | 2006-09-06 |
| DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (K062316) | Dade Behring, Inc. | 2006-09-06 |
| DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) (K062034) | Dade Behring, Inc. | 2006-09-06 |
| HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 (K060765) | Hemocue AB | 2006-09-06 |
| CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) (K060578) | Scantibodies Laboratory, Inc. | 2006-08-30 |
| DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 (K061839) | Dade Behring, Inc. | 2006-08-29 |
| DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 (K061719) | Dade Behring, Inc. | 2006-08-25 |
| DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) (K062122) | Dade Behring, Inc. | 2006-08-25 |
| DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) (K061923) | Dade Behring, Inc. | 2006-08-25 |
| N LATEX CDT (K060677) | Dade Behring, Inc. | 2006-08-25 |
| ABX PENTRA 400: LIPOPROTEINS (K060854) | Horiba Abx | 2006-08-24 |
| DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K062236) | Dade Behring, Inc. | 2006-08-21 |
| DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 (K061838) | Dade Behring, Inc. | 2006-08-21 |
| THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (K062128) | Dade Behring, Inc. | 2006-08-21 |
| MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K062195) | Lifescan, Inc. | 2006-08-16 |
| CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 (K062152) | Dade Behring, Inc. | 2006-08-16 |
| ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P (K060325) | Horiba Abx | 2006-08-16 |
| DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 (K061885) | Dade Behring, Inc. | 2006-08-14 |
| ACCU-CHEK AVIVA TEST STRIPS (K060620) | Roche Diagnostics Corp. | 2006-08-11 |
| ACON URINALYSIS REAGENT STRIPS (K061559) | Acon Laboratories Co. | 2006-08-11 |
| DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 (K061750) | Dade Behring, Inc. | 2006-08-11 |
| HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K060318) | Horiba Abx | 2006-08-08 |
| DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 (K061107) | Thermo Electron OY | 2006-08-08 |
| DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061793) | Dade Behring, Inc. | 2006-08-07 |
| DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH (K062055) | Dade Behring, Inc. | 2006-08-07 |
| OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 (K061730) | Osmetech, Inc. | 2006-08-04 |
| DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) (K061703) | Dade Behring, Inc. | 2006-08-02 |
| ACTIVE RENIN IRMA (K061758) | Diagnostic Systems Laboratories, Inc. | 2006-07-28 |
| ELEMENT BLOOD GLUCOSE TEST SYSTEM (K060793) | Home Diagnostics, Inc. | 2006-07-25 |
| GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K060205) | Horiba Abx | 2006-07-21 |
| DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A (K060619) | Diazyme Laboratories | 2006-07-21 |
| I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) (K053597) | I-Stat Corporation | 2006-07-21 |
| VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS (K061588) | Ortho-Clinical Diagnostics, Inc. | 2006-07-21 |
| RANDOX LIQUID PROTEIN CALIBRATOR (K061056) | Randox Laboratories, Ltd. | 2006-07-20 |
| DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) (K061818) | Dade Behring, Inc. | 2006-07-18 |
| DAVID PREGNANCY TEST (MIDSTREAM) (K053236) | Runbio Biotech Co.,Ltd | 2006-07-18 |
| DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260 (K061751) | Dade Behring, Inc. | 2006-07-13 |
| PRODIGY BLOOD GLUCOSE TEST SYSTEM (K060467) | Diagnostic Devices, Inc. | 2006-07-13 |
| DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) (K061702) | Dade Behring, Inc. | 2006-07-10 |
| ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 (K061181) | Taidoc Technology Corporation | 2006-07-06 |
| ADVIA IMS CPSA CONTROL (K061137) | Bayer Healthcare, LLC | 2006-07-06 |
| PRODIGY (K053593) | Diagnostic Devices, Inc. | 2006-07-06 |
| BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS (K061139) | Bayer Healthcare, LLC | 2006-07-06 |
| DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 (K061390) | Dade Behring, Inc. | 2006-07-05 |
| E.P.T. CERTAINTY 1-STEP PREGNANCY TEST (K061769) | Unipath , Ltd. | 2006-07-03 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS (K060480) | Ortho-Clinical Diagnostics | 2006-07-03 |
| DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 (K061218) | Dade Behring, Inc. | 2006-06-30 |
| CREATININE (K061193) | Abbott Laboratories, Inc. | 2006-06-23 |
| DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT (K060510) | Drew Scientific , Ltd. | 2006-06-19 |
| MULTI-USE ELECTRONIC PREGNANCY TEST (K060825) | Mizuho USA, Inc. | 2006-06-19 |
| EZ SMART-168 GLUCOSE MONITORING SYSTEM (K052818) | Tyson Bioresearch, Inc. | 2006-06-16 |
| VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 (K061464) | Ortho-Clinical Diagnostics, Inc. | 2006-06-15 |
| VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE (K060364) | Teco Diagnostics | 2006-06-15 |
| ABBOTT AXSYM TROPONIN-I ADV (K060875) | Abbott Laboratories | 2006-06-14 |
| DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR (K061296) | Diazyme Laboratories | 2006-06-13 |
| ICHEM 100 URINE CHEMISTRY ANALYZER (K060280) | Iris International, Inc. | 2006-06-13 |
| THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) (K061328) | E-San Limited | 2006-06-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 (K060632) | Ortho-Clinical Diagnostics, Inc. | 2006-06-06 |
| GLUCOPACK (K052469) | Healthpia America Corp. | 2006-06-05 |
| ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 (K061282) | Beckman Coulter, Inc. | 2006-06-02 |
| DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (K061251) | Dade Behring, Inc. | 2006-05-31 |
| NOD CHEMISTRY CONTROL (K060850) | Bioresource Technology, Inc. | 2006-05-30 |
| CARDIOIMMUNE XL CARDIAC MARKER CONTROL (K061196) | Microgenics Corp. | 2006-05-30 |
| CLEARBLUE EASY DIGITAL PREGNANCY TEST (K060128) | Unipath , Ltd. | 2006-05-25 |
| CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB (K061182) | Cliniqa Corporation | 2006-05-25 |
| PURE-AID PREGNANCY TEST (K053452) | Bio Focus Co., Lt. | 2006-05-25 |
| DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE (K061238) | Dade Behring, Inc. | 2006-05-25 |
| ARCHITECT BNP ASSAY, MODEL 8K28 (K060964) | Fujirebio Diagnostics,Inc. | 2006-05-25 |
| ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM (K061118) | Lifescan, Inc. | 2006-05-19 |
| DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 (K060502) | Dade Behring, Inc. | 2006-05-18 |
| COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM (K061048) | Roche Diagnostics Corp. | 2006-05-17 |