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

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