FDA 510(k) Application Details - K191595

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K191595
Device Name	Immunoassay Method, Troponin Subunit
Applicant	Abbott Laboratories Diagnostics Division Dept. 09AA, Bldg. AP8, 100 Abbott Park Road Abbott Park, IL 60064-6038 US Other 510(k) Applications for this Company
Contact	Judi Wallach 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	06/17/2019
Decision Date	09/13/2019
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