BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

TOTAL IGE-FAST TEST

FDA 510(k)

FDA Class 2 ·Immunology

Systane iLux2

FDA 510(k)

FDA Class 2 ·Ophthalmic

POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

ABBOTT AXSYM MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT

FDA 510(k)

FDA Class 2 ·Immunology

MESACUP TEST PR-3

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIMETRIC PLUS IGA REAGENT KIT

FDA 510(k)

FDA Class 2 ·Immunology

CATALYS Precision Laser system

FDA 510(k)

FDA Class 2 ·Ophthalmic

TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES

FDA 510(k)

FDA Class 2 ·Ophthalmic

TIA-IGG REAGENT & CALIBRATOR SETS

FDA 510(k)

FDA Class 2 ·Immunology

Access CEA

FDA 510(k)

FDA Class 2 ·Immunology

EIA MONOCLONAL TOTAL IGE KIT

FDA 510(k)

FDA Class 2 ·Immunology

VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D

FDA 510(k)

FDA Class 2 ·Ophthalmic

ANTI-GBM ANTIBODIES QUANTITATIVE KIT

FDA 510(k)

FDA Class 2 ·Immunology

Vitreq disposable laser probes, light fibers and Chandelier

FDA 510(k)

FDA Class 2 ·Ophthalmic

SENSIBEAD EIA IGE KIT

FDA 510(k)

FDA Class 2 ·Immunology

RA 80 EIKEN

FDA 510(k)

FDA Class 2 ·Immunology