Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10

FDA 510(k)

FDA Class 2 ·Radiology

SCD STERILE CONNECTION DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIM (N/A)

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LOCI 8 CALIBRATOR, MODEL KC 646

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION TPSA CALIBRATOR, MODEL #RC459

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

DU PONT TOBRAMYCIN ASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CYCLOSPORINE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology