FDA 510(k) Application Details - K955356

Device Classification Name	Radioimmunoassay, Estriol   More FDA Info for this Device
510(K) Number	K955356
Device Name	Radioimmunoassay, Estriol
Applicant	DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US Other 510(k) Applications for this Company
Contact	JOHN WILLIS Other 510(k) Applications for this Contact
Regulation Number	862.1265   More FDA Info for this Regulation Number
Classification Product Code	CGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/1995
Decision Date	05/15/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review