OCULAR RESPONSE ANALYZER

FDA 510(k)

FDA Class 2 ·Ophthalmic

NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A

FDA 510(k)

FDA Class 2 ·Ophthalmic

AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

EVOLUTION PHACOMULSIFIER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA SM ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TEST, (IVDP) SMOOTHMUSCLE ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VITRE CON

FDA 510(k)

FDA Class 2 ·Ophthalmic

ANTISERUM TO HUMAN C-REACTIVE PROTEINS

FDA 510(k)

FDA Class 2 ·Immunology

BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMX FERRITIN

FDA 510(k)

FDA Class 2 ·Immunology

VAC-G (GUILLOTINE VITRECTOR)

FDA 510(k)

FDA Class 2 ·Ophthalmic

ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

Maverick RNP Assay and Maverick Diagnostic System

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology

NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS

FDA 510(k)

FDA Class 2 ·Ophthalmic