FDA 510(k) Application Details - K193204

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K193204
Device Name	Test, Qualitative And Quantitative Factor Deficiency
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	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GGP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2019
Decision Date	07/17/2020
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