FDA 510(k) Applications for Medical Device Product Code "CGF"
(Radioimmunoassay, Estrone)

FDA 510(k) Number Applicant Device Name Decision Date
K833406 CORNING MEDICAL & SCIENTIFIC IMMOPHASE D-TE 3 RADIOIMMUNOASSAY 01/24/1984
K935013 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ESTRONE (DSL 8700) 06/16/1994
K970915 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ESTRONE-SULFATE RIA 05/16/1997
K864966 DIAGNOSTICS BIOCHEM CANADA, INC. ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE 01/09/1987


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