FDA 510(k) Application Details - K211181

Device Classification Name	More FDA Info for this Device
510(K) Number	K211181
Device Name	Idylla MSI Test
Applicant	Biocartis NV Generaal De Wittelaan 11 B3 Mechelen 2800 BE Other 510(k) Applications for this Company
Contact	Elnaz Jokar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2021
Decision Date	02/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review