FDA 510(k) Application Details - DEN200044

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200044
Device Name	Eonis SCID-SMA Kit
Applicant	PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Casey Fox Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2020
Decision Date	11/09/2022
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MG -
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review