FDA 510(k) Application Details - K193556

Device Classification Name	Activated Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K193556
Device Name	Activated Partial Thromboplastin
Applicant	Precision BioLogic 140 Eileen Stubbs Avenue Dartmouth B3B 0A9 CA Other 510(k) Applications for this Company
Contact	Karen Black Other 510(k) Applications for this Contact
Regulation Number	864.7925   More FDA Info for this Regulation Number
Classification Product Code	GFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2019
Decision Date	10/23/2020
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