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

DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

FDA 510(k)

FDA Class 2 ·Physical Medicine

DIMENSION SPECIAL PROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KINESTHETICS MODEL 2000 NMS

FDA 510(k)

FDA Class 2 ·Physical Medicine

URINARY/CEREBROSPINAL FLUID PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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