FDA 510(k) Application Details - DEN190032

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190032
Device Name	HemosIL Liquid Anti-Xa
Applicant	Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Carol Marble Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2019
Decision Date	09/17/2020
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review