FDA 510(k) Application Details - K213875

Device Classification Name	U.V. Spectrometry, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K213875
Device Name	U.V. Spectrometry, Tricyclic Antidepressant Drugs
Applicant	Microgenics Corporation 46500 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	12/13/2021
Decision Date	12/21/2022
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