FDA 510(k) Application Details - K201256

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K201256
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	Procise Diagnostics 9449 Carroll Park Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Dan Kiser Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2020
Decision Date	11/04/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review