FDA 510(k) Application Details - K203035

Device Classification Name	More FDA Info for this Device
510(K) Number	K203035
Device Name	Eonis SCID-SMA kit
Applicant	PerkinElmer Inc 940 Winter St Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Eva Nalian Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2020
Decision Date	11/09/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review