Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

SEKURE Acetaminophen L3K Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

DELFIA DIGOXIN

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

LBK 1244 DELFIA HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DELFIA(TM) FERRITIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

DELFIA(TM) HIGE KIT

FDA 510(k)

FDA Class 2 ·Immunology

DELFIA (TM) HTSH KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GOLD GATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DELFIA(TM) THYROXINE (T4) KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DELFIA (TM) HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECTRORETINOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETeval Visual Electrodiagnostic Device

FDA 510(k)

FDA Class 2 ·Neurology