FDA 510(k) Application Details - K230839

Device Classification Name	More FDA Info for this Device
510(K) Number	K230839
Device Name	Concentriq Dx
Applicant	Proscia, Inc. 1700 Market St. 23rd Floor Philadelphia, PA 19103 US Other 510(k) Applications for this Company
Contact	Kim Rendon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2023
Decision Date	02/08/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review