FDA 510(k) Application Details - K970425

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K970425
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE. YORBA LINDA, CA 92887 US Other 510(k) Applications for this Company
Contact	MIN-LEE CHENG Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/1997
Decision Date	03/06/1997
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