FDA 510(k) Application Details - K970008

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K970008
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	BIONIKE, INC. 1015 GRANDVIEW DR. SOUTH SAN FRANCISCO, CA 94080-4910 US Other 510(k) Applications for this Company
Contact	JANIS FREESTONE 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	01/02/1997
Decision Date	02/18/1997
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