FDA 510(k) Application Details - K231776

Device Classification Name	More FDA Info for this Device
510(K) Number	K231776
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	Wendy Royalty 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	06/16/2023
Decision Date	07/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review