IMMULITE 2000 3RD GENERATION PSA

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION PSA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA (ON ELECSYS 1010)

FDA 510(k)

FDA Class 2 ·Immunology

FREND PSA PLUS (reagent cartridge)

FDA 510(k)

FDA Class 2 ·Immunology

FREND PSA PLUS (REAGENT CARTRIDGE)

FDA 510(k)

FDA Class 2 ·Immunology

AUGMENT AND SCREW, PSA TYPE

FDA 510(k)

FDA Class 2 ·Orthopedic

ANALYZER, PACER SYSTEM, PSA-5

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIVE PSA IRMA (DSL-9700)

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA, MODEL # ELECSYS 1010

FDA 510(k)

FDA Class 2 ·Immunology

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PACER SENSING ANALYZER (PSA 100)

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY

IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)

FDA 510(k)

FDA Class 2 ·Immunology

PACING SYSTEM ANALYZER PSA SCE-22

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000