FDA 510(k) Application Details - K242127

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K242127
Device Name	Instrument, Coagulation, Automated
Applicant	Instrumentation Laboratory (IL) Co. 180 Hartwell Road Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Sneh Pingle Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	GKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2024
Decision Date	08/16/2024
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