FDA 510(k) Application Details - K965109

Device Classification Name	Radioimmunoassay, Estradiol   More FDA Info for this Device
510(K) Number	K965109
Device Name	Radioimmunoassay, Estradiol
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. CONCORD, CA 94524 US Other 510(k) Applications for this Company
Contact	Yvette Lloyd Other 510(k) Applications for this Contact
Regulation Number	862.1260   More FDA Info for this Regulation Number
Classification Product Code	CHP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/1996
Decision Date	02/18/1997
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