FDA 510(k) Application Details - K231020

Device Classification Name	U.V. Spectrometry, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K231020
Device Name	U.V. Spectrometry, Tricyclic Antidepressant Drugs
Applicant	Microgenics Corporation 45600 Kato Road Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Pranjali Shinde Other 510(k) Applications for this Contact
Regulation Number	862.3910   More FDA Info for this Regulation Number
Classification Product Code	LFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2023
Decision Date	11/17/2023
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