ECG SIMULATOR MODEL ECGPLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESS FERRITIN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS(R) TOTAL IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VENTILATOR TEST LUNG

FDA 510(k)

FDA Class 2 ·Anesthesiology

SM-EXTRA WIDE (RBM) IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

IDA-4 AND IPT-MC

FDA 510(k)

FDA Class 2 ·General Hospital

ACCESS VITAMIN B12 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NURITE II VRM SINGLE (ELEC. NERVE STIM)

FDA 510(k)

FDA Class 2 ·Neurology

MODELS IDA-2 PLUS AND IPT-1

FDA 510(k)

FDA Class 2 ·General Hospital

SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515

FDA 510(k)

FDA Class 2 ·Physical Medicine

RADID DRUG SCREEN 5-PANEL TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

UREA NITROGEN, KINETIC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADULT VENTILATOR TESTER VT-1

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SALICYLATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology