SERO/TEX MONO TEST

FDA 510(k)

FDA Class 2 ·Immunology

ADP ANA IFA TEST

FDA 510(k)

FDA Class 2 ·Immunology

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Anterion

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ANCA SCREEN ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

FDA 510(k)

FDA Class 2 ·Ophthalmic

STAT

FDA 510(k)

FDA Class 2 ·Ophthalmic

P200TE (A10700)

FDA 510(k)

FDA Class 2 ·Ophthalmic

VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-SM

FDA 510(k)

FDA Class 2 ·Immunology

OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

FDA 510(k)

FDA Class 2 ·Immunology

Specular Microscope CEM-530

FDA 510(k)

FDA Class 2 ·Ophthalmic

FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

FDA 510(k)

FDA Class 2 ·Ophthalmic

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology

STANDARD PHACO TIP 15, 30, 45, 60

FDA 510(k)

FDA Class 2 ·Ophthalmic