FDA 510(k) Application Details - K970386

Device Classification Name	Radioimmunoassay, Estradiol   More FDA Info for this Device
510(K) Number	K970386
Device Name	Radioimmunoassay, Estradiol
Applicant	CHIRON DIAGNOSTICS CORP. 63 NORTH ST. MEDFIELD, MA 02052 US Other 510(k) Applications for this Company
Contact	THOMAS F FLYNN 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	02/03/1997
Decision Date	06/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review