FDA 510(k) Application Details - K240984

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K240984
Device Name	Immunoassay Method, Troponin Subunit
Applicant	Abbott Point of Care Inc. 400 College Road East Princeton, NJ 08540 US Other 510(k) Applications for this Company
Contact	Jacquelyn Gesumaria 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	04/10/2024
Decision Date	01/03/2025
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