FDA 510(k) Application Details - K013062

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K013062
Device Name	Immunoassay Method, Troponin Subunit
Applicant	BIOCHECK, INC. 9418 LASAINE AVE. NORTHRIDGE, CA 91325 US Other 510(k) Applications for this Company
Contact	ROBIN J HELLEN 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	09/12/2001
Decision Date	01/08/2002
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