FDA 510(k) Application Details - K242505

Device Classification Name	Fluorometric, Cortisol   More FDA Info for this Device
510(K) Number	K242505
Device Name	Fluorometric, Cortisol
Applicant	Roche Diagnostics 9115 Hague Rd. Building B Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Chunhong (Emma) Tao Other 510(k) Applications for this Contact
Regulation Number	862.1205   More FDA Info for this Regulation Number
Classification Product Code	JFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2024
Decision Date	07/17/2025
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