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Device

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ADVIA Centaur CA 15-3 assay

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT CA 15-3 ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYSCA 15-3 II ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)

FDA 510(k)

FDA Class 2 ·Immunology

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS CA 15-3 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

FDA 510(k)

FDA Class 2 ·Immunology

Access BR Monitor

FDA 510(k)

FDA Class 2 ·Immunology

BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur BR

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM CA 15-3

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE® 2000 BR-MA

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G CA15-3

FDA 510(k)

FDA Class 2 ·Immunology

CENTOCOR CA 15-3 RIA MODEL NO. 800-033

FDA 510(k)

FDA Class 2 ·Immunology

CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

AIA-PACK BRCA, ST AIA PACK BRCA

FDA 510(k)

FDA Class 2 ·Immunology

IMX CA 15-3

FDA 510(k)

FDA Class 2 ·Immunology

TRUQUANT BR RIA

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK

FDA 510(k)

FDA Class 2 ·Immunology