FDA 510(k) Application Details - DEN210056

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210056
Device Name	Procise IFX
Applicant	ProciseDx Inc. 9449 Carroll Park Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Kurtis R. Bray Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2021
Decision Date	09/29/2023
Decision	DENG -
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review