ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THEROX INFUSION CATHETER, MODEL INCA-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARBON DIOXIDE LIQUID STABLE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AUTO HDL CHOLESTEROL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WIELISA ANCA SCREENING KIT TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE

FDA 510(k)

FDA Class 2 ·General Hospital

EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ZTX ULTRASONIC DIATHERMY DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

MEDSURG STERILE O.R. TOWELS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

EXTRAORAL HEADGEAR

FDA 510(k)

FDA Class 2 ·Dental

CONMED ECG/EKG ELECTRODES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)

FDA 510(k)

FDA Class 2 ·Cardiovascular