FDA 510(k) Application Details - K981512

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K981512
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	SKD, INC. A BECKMAN COULTER CO. 1050 PAGE MILL ROAD,BLDG. 2B PALO ALTO, CA 94303-0105 US Other 510(k) Applications for this Company
Contact	KAREN RICHARDS 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	04/28/1998
Decision Date	05/28/1998
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