FDA 510(k) Application Details - K974060

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K974060
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	INTERNATIONAL NEWTECH DEVELOPMENT, INC. 1629 FOSTERS WAY DELTA, BRITISH COLUMBIA V3M 6S7 CA Other 510(k) Applications for this Company
Contact	BENNY WANG 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	10/27/1997
Decision Date	04/09/1998
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