FDA 510(k) Application Details - K211973

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K211973
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	Microgenics Corporation 46500 Kato Road Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Nikhita Tandon Other 510(k) Applications for this Contact
Regulation Number	862.3250   More FDA Info for this Regulation Number
Classification Product Code	DIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2021
Decision Date	09/24/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review