FDA 510(k) Application Details - K014024

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K014024
Device Name	Immunoassay Method, Troponin Subunit
Applicant	FIRST MEDICAL, INC. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND 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	12/06/2001
Decision Date	12/18/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review