FDA 510(k) Application Details - K974839

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K974839
Device Name	Immunoassay Method, Troponin Subunit
Applicant	FIRST MEDICAL, INC. 530 LOGUE AVE. MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	VAN N JOHNSON 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	12/24/1997
Decision Date	02/04/1998
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