ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS FOLATE ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Access hs Tnl

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS AMPHETAMINE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON SYSTEMS LIPID CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR

FDA 510(k)

FDA Class 2 ·Immunology

IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology