FDA 510(k) Application Details - K251968

Device Classification Name	System, Fibrinogen Determination   More FDA Info for this Device
510(K) Number	K251968
Device Name	System, Fibrinogen Determination
Applicant	Instrumentation Laboratory (IL) Co. 180 Hartwell Rd Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Kirivann Chhoeun Other 510(k) Applications for this Contact
Regulation Number	864.7340   More FDA Info for this Regulation Number
Classification Product Code	KQJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2025
Decision Date	07/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review