FDA 510(k) Application Details - K020968

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K020968
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	PAN PROBE BIOTECH, INC. 8515 ARJONS DR., SUITE A SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	ALICE H YU 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	03/26/2002
Decision Date	07/15/2002
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	Y
Expedited Review