GENTAMICIN FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

MySegmenter (v2.0.0)

FDA 510(k)

FDA Class 2 ·Radiology

DUPONT PHENOBARBITAL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA URINE BARBITURATES SCREEN METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VANCOMYCIN FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DUPONT ACA VANCOMYCIN (VANC) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Neuhat Hair Growth System; ibeauty.com Laser Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT MAMMOGRAPHY CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

FDA 510(k)

FDA Class 2 ·Immunology

Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COBES SURGICAL DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVANCED D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology