FDA 510(k) Application Details - K974721

Device Classification Name	Radioimmunoassay, Estriol   More FDA Info for this Device
510(K) Number	K974721
Device Name	Radioimmunoassay, Estriol
Applicant	BAYER CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	GABRIEL J MURACA JR. 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	12/18/1997
Decision Date	03/03/1998
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