FDA 510(k) Application Details - K221359

Device Classification Name	System, Multipurpose For In Vitro Coagulation Studies   More FDA Info for this Device
510(K) Number	K221359
Device Name	System, Multipurpose For In Vitro Coagulation Studies
Applicant	Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Nikita Malladi Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	JPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2022
Decision Date	09/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review