FDA 510(k) Application Details - K230994

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K230994
Device Name	Immunoassay Method, Troponin Subunit
Applicant	Abbott Laboratories Diagnostics Division 100 Abbott Park Rd. Dept. 09AA, Building CP01-2 Abbott Park, IL 60064 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	04/07/2023
Decision Date	05/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review