AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-SM/RNP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-SS-A/RO ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-SCL-70 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANA SCREEN ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-SM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Lung Nodule Assessment and Comparison Option (LNA)

FDA 510(k)

FDA Class 2 ·Radiology

Dyna-Vision Telemonitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

C. Difficile Toxin Gene Amplification Assay

FDA classification

FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS

FDA 510(k)

FDA Class 2 ·Microbiology

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

XPERCT REL. 3

FDA 510(k)

FDA Class 2 ·Radiology

Ingenia Elition and MR 7700 MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

Philips IntelliSite Pathology Solution 5.1

FDA 510(k)

FDA Class 2 ·Pathology

Brain Perfusion (BP) application

FDA 510(k)

FDA Class 2 ·Radiology