COAT-A-COUNT (TM) THEOPHYLLINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COMPRESSIBLE LIMB SLEEVE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

INFUSION CATHETER W/SIDE HOLES

FDA 510(k)

FDA Class 2 ·Cardiovascular

U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000

FDA 510(k)

FDA Class 2 ·Radiology

TheraFace Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMMULITE OPIATES SCREEN/CONTROL MODULE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COAT-A-COUNT INTACT PTH IRMA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MINI-HALO(HAND-HELD) CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TRUSTEX COLA FLAVORD CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRACKER-25 INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT

FDA 510(k)

FDA Class 2 ·Dental

U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000

FDA 510(k)

FDA Class 2 ·Radiology

ALASTAT MICROPLATE MIXED ALLERGEN PANELS

FDA 510(k)

FDA Class 2 ·Immunology

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry