FDA 510(k) Application Details - K080851

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K080851
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	ANTICANCER INC 7917 OSTROW ST. SAN DIEGO, CA 92111 US Other 510(k) Applications for this Company
Contact	YUYING TAN Other 510(k) Applications for this Contact
Regulation Number	862.1377   More FDA Info for this Regulation Number
Classification Product Code	LPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2008
Decision Date	10/10/2008
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