FDA 510(k) Application Details - K050644

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K050644
Device Name	Immunoassay Method, Troponin Subunit
Applicant	VANCOUVER BIOTECH LTD. 9121 SHAUGHNESSY ST. VANCOUVER V6P 6R9 CA Other 510(k) Applications for this Company
Contact	ANDREW LEE Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	MMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2005
Decision Date	08/17/2005
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