TOTAL CONTAINMENT DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RAVEN DRY PRINTER

FDA 510(k)

FDA Class 2 ·Radiology

DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LITECURE THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

Atellica CH Amylase_2 (AMY_2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

DU PONT LINX HD-25 LASR IMAGER

FDA 510(k)

FDA Class 2 ·Radiology

LOCK-IN Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO N PROTEIN STANDARD SL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DU PONT ACA METHOTREXATE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

DU PONT DIMENSION C-REACTIVE PROTEIN METHOD

FDA 510(k)

FDA Class 2 ·Immunology

STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LOCI Total Vitamin D Total Assay, LOCI VITD CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

FDA 510(k)

FDA Class 2 ·Hematology

STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK

FDA 510(k)

FDA Class 2 ·Immunology