FDA 510(k) Application Details - K243543

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K243543
Device Name	Test, Time, Prothrombin
Applicant	iLine Microsystems S.L. Paseo Mikeletegi 69. Donostia 20009 ES Other 510(k) Applications for this Company
Contact	Miren Itsaso 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	11/15/2024
Decision Date	02/27/2025
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