FDA 510(k) Application Details - K023823

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K023823
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	ZER HITECH 1308 MORNINGSIDE PARK DR. ALPHARETTA, GA 30022 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR 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	11/15/2002
Decision Date	05/22/2003
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