FDA 510(k) Application Details - K230802

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K230802
Device Name	Test, Time, Prothrombin
Applicant	Universal Biosensors Pty Ltd 1 Corporate Avenue Rowville 3178 AU Other 510(k) Applications for this Company
Contact	Nosheen Hameed 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	03/23/2023
Decision Date	03/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review