FDA 510(k) Application Details - K212779

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K212779
Device Name	Test, Time, Prothrombin
Applicant	CoaguSense, Inc. 48377 Fremont Blvd. Suite 113 Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Michael Acosta 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	09/01/2021
Decision Date	10/05/2022
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