RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

FDA 510(k)

FDA Class 2 ·Radiology

KBL Sunlamp Products (= Device Bundling name)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IBL C3D-CIC EIA TEST

FDA 510(k)

FDA Class 2 ·Immunology

IBL C1Q-CIC CIA TEST

FDA 510(k)

FDA Class 2 ·Immunology

CLEEN-ABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BUFFER PACK FOR ABL-1 & ABL-2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DRAGON X SPSL4HC, DRAGON X SPSL8HC

FDA 510(k)

FDA Class 2 ·Radiology

CORTISOL ELISA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cortisol Saliva Luminescence Immunoassay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

3D-DOCTOR

FDA 510(k)

FDA Class 2 ·Radiology

ACETYLCHOLINE RECEPTOR AB (ARAB)RRA

FDA 510(k)

FDA Class 2 ·Immunology

IBL 5000 Tanning Booth

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUICK PRIME LINES, #'S BPL-12, BPL-48 &

FDA 510(k)

FDA Class 2 ·Cardiovascular

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

CUFF-ABLE PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BBL GASPAK POUCH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROFILE BBL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery