INCSTAR HSZ I/II IGG ELISA ASSAY

FDA 510(k)

FDA Class 1 ·Pathology

ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OAC (OPTICAL ASPIRATING CURETTE)

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

ML BLADE, MODEL ML7030

FDA 510(k)

FDA Class 1 ·Ophthalmic

BIONIME DIABETES MANAGEMENT SYSTEM VI.0

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LARIAT PALATE EXPANDER

FDA 510(k)

FDA Class 1 ·Dental

PERIMETRICS PERIOMETER

FDA 510(k)

FDA Class 1 ·Dental

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT IMX TOTAL PSA

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT ARCHITECT TOTAL PSA

HELA-229/HELA CELLS

FDA 510(k)

FDA Class 1 ·Hematology

HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

PLASTIC SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT AXSYM TOTAL PSA ASSAY

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

FDA 510(k)

FDA Class 1 ·General Hospital