FDA 510(k) Application Details - K183390

Device Classification Name	System, Multipurpose For In Vitro Coagulation Studies   More FDA Info for this Device
510(K) Number	K183390
Device Name	System, Multipurpose For In Vitro Coagulation Studies
Applicant	Diagnostic Grifols, S.A. Passeig Fluvial, 24 Parets del Valles 08150 ES Other 510(k) Applications for this Company
Contact	Joaquin Alberto Tamparillas 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	12/06/2018
Decision Date	08/21/2019
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