FDA 510(k) Application Details - K250513

Device Classification Name	More FDA Info for this Device
510(K) Number	K250513
Device Name	IntelliSep Test (CV-ICG-048)
Applicant	Cytovale, Inc. 2 Tower Place 18th Floor South San Francisco, CA 94404 US Other 510(k) Applications for this Company
Contact	Sarah Esterquest Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2025
Decision Date	03/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review