FDA 510(k) Application Details - K030058

Device Classification Name	Radioimmunoassay, Follicle-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K030058
Device Name	Radioimmunoassay, Follicle-Stimulating Hormone
Applicant	EARLY DETECT, INC. 2950 NORTH GLASSELL ST. ORANGE, CA 92865 US Other 510(k) Applications for this Company
Contact	PETER GEORGE Other 510(k) Applications for this Contact
Regulation Number	862.1300   More FDA Info for this Regulation Number
Classification Product Code	CGJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/2003
Decision Date	07/30/2003
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