FDA 510(k) Application Details - K183530

Device Classification Name	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System   More FDA Info for this Device
510(K) Number	K183530
Device Name	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Applicant	Akonni Biosystems Inc. 400 Sagner Ave, Suite 300 Frederick, MD 21701 US Other 510(k) Applications for this Company
Contact	Charles Daitch Other 510(k) Applications for this Contact
Regulation Number	862.3360   More FDA Info for this Regulation Number
Classification Product Code	ODW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2018
Decision Date	05/24/2019
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