FDA 510(k) Application Details - K963408

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K963408
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	SUN BIOMEDICAL LABORATORIES, INC. 2040 FAIRFAX AVE. CHERRY HILL, NJ 08003 US Other 510(k) Applications for this Company
Contact	MING SUN, PH.D. 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	08/29/1996
Decision Date	10/18/1996
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