FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

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

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

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

Multi-Link X2 ECG Cable and Lead Wire System

FDA 510(k)

FDA Class 2 ·Cardiovascular

RF CHOKE CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Multi-Link X2 ECG Cable and Leadwire System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES

FDA 510(k)

FDA Class 2 ·Cardiovascular