FDA 510(k) Application Details - K201185

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K201185
Device Name	Test, Time, Prothrombin
Applicant	iLine Microsystems S.L. Paseo Mikeletegi, 69 San Sebastian-Donostia 20009 ES Other 510(k) Applications for this Company
Contact	Miren Itaso Hormaeche Other 510(k) Applications for this Contact
Regulation Number	864.7750   More FDA Info for this Regulation Number
Classification Product Code	GJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2020
Decision Date	12/18/2020
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