MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

PROSTATE SPECIFIC ANTIGEN METHOD

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

OPUS PSA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

FDA 510(k)

FDA Class 2 ·Immunology

TOTAL PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

BAYER PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)

FDA Class 2 ·Immunology

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Platinum dRF Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

BOBCAT DX

FDA 510(k)

FDA Class 2 ·Physical Medicine

QUANTA LITE SS-A 52 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

SPERTILITE PHOTOTHERAPY LAMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)

FDA 510(k)

FDA Class 2 ·Dental

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System