APERIO EPATHOLOGY EIHC IVD SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

SCANSCOPE XT SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

SCANVIEW HER2/NEU FISH SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)

FDA 510(k)

FDA Class 2 ·Hematology

QCA (VERSION 3.1)

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR V LEIDEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

HEMOSIL F11 & FV DNA CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

exCellerator Cervical Collection Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra

FDA 510(k)

FDA Class 2 ·Hematology

CELLSEARCH CIRCULATING TUMOR CELL KIT

FDA 510(k)

FDA Class 2 ·Immunology

DAKO PAP KIT K505

FDA 510(k)

FDA Class 2 ·Immunology

PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

FDA 510(k)

FDA Class 2 ·Hematology

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

FDA 510(k)

FDA Class 2 ·General Hospital

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16

FDA 510(k)

FDA Class 2 ·Hematology

CYTOLOGY BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Idylla MSI Test

FDA 510(k)

FDA Class 2 ·Immunology

INFINITI SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology