FDA 510(k) Application Details - K955284

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K955284
Device Name	Immunoassay Method, Troponin Subunit
Applicant	BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	PHILIP FANTASIA 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	11/16/1995
Decision Date	01/25/1996
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