FDA 510(k) Application Details - K220026

Device Classification Name	Drug Metabolizing Enzyme Genotyping Systems   More FDA Info for this Device
510(K) Number	K220026
Device Name	Drug Metabolizing Enzyme Genotyping Systems
Applicant	Genomadix Inc. 340 Legget Drive, Suite 180 Kanata (Ottawa) CA Other 510(k) Applications for this Company
Contact	Amanda Dwyer Other 510(k) Applications for this Contact
Regulation Number	862.3360   More FDA Info for this Regulation Number
Classification Product Code	NTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2022
Decision Date	03/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review