ROTAFLOW CENTRIFUGAL PUMP SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sunny Cup and Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIMENSION TRNF FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK

FDA 510(k)

FDA Class 2 ·Immunology

ACA PLUS FREE THYROXINE(FT4) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

FERRITIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

DU PONT LIQUID MULTI-ANALYTE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iSage Rx (iSage Rx Basal Insulin Titration)

FDA 510(k)

FDA Class 2 ·Anesthesiology

DELL UP3017 with QUBYX PerfectLum bundle

FDA 510(k)

FDA Class 2 ·Radiology

N LATEX IGA

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION SPECIAL PROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GORE 3.0T TORSO ARRAY

FDA 510(k)

FDA Class 2 ·Radiology

ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N LATEX FERRITIN

FDA 510(k)

FDA Class 2 ·Immunology