BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

V-TREND IM DRY-SPOT TEST

FDA 510(k)

FDA Class 2 ·Immunology

IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR

FDA 510(k)

FDA Class 2 ·General Hospital

BAYER ADVIA IMS SYSTEM; 200 + 3

FDA 510(k)

FDA Class 2 ·Immunology

MOST HEX INTRAMEDULLARY (I/M) STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OSS/Arcos IM Total Femur Rod

FDA 510(k)

FDA Class 2 ·Orthopedic

IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST

FDA 510(k)

FDA Class 2 ·Immunology

ABX MICROS CRP 200, OPTION IM

FDA 510(k)

FDA Class 2 ·Hematology

Cardinal Health Trochanteric IM Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

Acumed Small Bone IM Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV)

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)

FDA 510(k)

FDA Class 2 ·Immunology

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

FDA 510(k)

FDA Class 2 ·Orthopedic

ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Atellica IM High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST

FDA 510(k)

FDA Class 2 ·Immunology

Renovo Life Small Bone IM Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

FUJI MEDICAL LASER IMAGER FL-IM D

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV) Assay