FDA 510(k) Application Details - DEN200001

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200001
Device Name	Cell-Free DNA BCT
Applicant	Streck, Inc. 7002 S. 109th Street La Vista, NE 68128 US Other 510(k) Applications for this Company
Contact	Deborah Kipp Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2020
Decision Date	08/07/2020
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review