FDA 510(k) Applications for Medical Device Product Code "CGI"
(Radioimmunoassay, Estriol)

FDA 510(k) Number Applicant Device Name Decision Date
K974721 BAYER CORP. UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) 03/03/1998
K955356 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL 05/15/1996
K962875 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA 08/23/1996


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