FDA 510(k) Application Details - K172783

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K172783
Device Name	Immunoassay Method, Troponin Subunit
Applicant	Beckman Coulter, Inc. 1000 Lake Hazeltine Drive MS R-540-C Immunodiagnostic Development Center Chaska, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	Kerrie Sue Oetter 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	09/15/2017
Decision Date	06/12/2018
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