FDA 510(k) Application Details - K220991

Device Classification Name	More FDA Info for this Device
510(K) Number	K220991
Device Name	IntelliSep test
Applicant	Cytovale Inc. 150 Executive Park Blvd, Suite 4100 San Francisco, CA 94134 US Other 510(k) Applications for this Company
Contact	Juliet Carrara 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	04/04/2022
Decision Date	12/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review