FDA 510(k) Application Details - K211485

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K211485
Device Name	Test, Time, Prothrombin
Applicant	Diagnostica Stago SAS 3 allΘe ThΘrΘsa AsniΘres sur Seine 92600 FR Other 510(k) Applications for this Company
Contact	Pauline Vasselon 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	05/13/2021
Decision Date	12/23/2022
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