FDA 510(k) Application Details - K180486

Device Classification Name	Plasma, Coagulation Factor Deficient   More FDA Info for this Device
510(K) Number	K180486
Device Name	Plasma, Coagulation Factor Deficient
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	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2018
Decision Date	03/22/2018
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