FDA 510(k) Application Details - K041728

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K041728
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	IMMUNOSTICS, INC. 3505 SUNSET AVE. OCEAN, NJ 07712 US Other 510(k) Applications for this Company
Contact	JEFFREY FLEISHMAN Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2004
Decision Date	08/11/2004
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