FDA 510(k) Application Details - DEN200062

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200062
Device Name	Parsortix PC1 Device
Applicant	ANGLE Europe Ltd. 10 Nugent Road Guildford GU2 7AF GB Other 510(k) Applications for this Company
Contact	Andrew Newland Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2020
Decision Date	05/24/2022
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MG -
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review