FDA 510(k) Application Details - K041811

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K041811
Device Name	Immunoassay Method, Troponin Subunit
Applicant	ABBOTT LABORATORIES DEPT. 9V6, BLDG. AP6C-3 100 ABBOTT PARK ROAD ABBOTT PARK, IL 60064-6095 US Other 510(k) Applications for this Company
Contact	MARGARET PROCHNIAK 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	07/06/2004
Decision Date	09/10/2004
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