ACCESS RUBELLA IGG

FDA 510(k)

FDA Class 2 ·Microbiology

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLENDERTONE Evolve Abs, Type 735

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYSTEM-MINI, MODELS: 390, E30

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Advanced LumFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

M-1 PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

RAPIDONE - MARIJUANA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ET-3 EMERGENCY TRANSPORT VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1

FDA 510(k)

FDA Class 2 ·Microbiology

IC-5 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Dental 5 Multi Diode laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPID READER

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCESS SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

TV-100

FDA 510(k)

FDA Class 2 ·Anesthesiology

COLORIMETRIC BUN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INDEX SPO2 SIMULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

FDA 510(k)

FDA Class 2 ·Hematology