Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORTEC MI-306, MI-327 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

DUET GLUCOSE CONTROL MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GO GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LXN BLOOD GLUCOSE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LXN FRUCTOSAMINE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

PERSONAL GLUCOSE CONTROL CHARTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DUET II GLUCOSE CONTROL MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SEKURE Acetaminophen L3K Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

LBK 1244 DELFIA HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GOLD GATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECHO GEL (RAINFOREST)

FDA 510(k)

FDA Class 2 ·Radiology

MEGA 5.5 SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG

FDA 510(k)

FDA Class 2 ·Cardiovascular

BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology