FDA 510(k) Application Details - K222831

Device Classification Name	Plasma, Coagulation Factor Deficient   More FDA Info for this Device
510(K) Number	K222831
Device Name	Plasma, Coagulation Factor Deficient
Applicant	Precision BioLogic Inc. 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	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2022
Decision Date	09/13/2023
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