FDA Product Code LFH: U.v. Spectrometry, Tricyclic Antidepressant Drugs
Leading manufacturers include Microgenics Corporation.
6
Total
6
Cleared
153d
Avg days
1995
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared U.v. Spectrometry, Tricyclic Antidepressant Drugs Devices (Product Code LFH)
6 devices
Cleared
Nov 17, 2023
Alinity c Tricyclic Antidepressants Reagent Kit
Microgenics Corporation
Toxicology
221d
Cleared
Dec 21, 2022
DRI TM Tricyclics Serum Tox Assay
Microgenics Corporation
Toxicology
373d
About Product Code LFH - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code LFH since 1995, with 6 receiving FDA clearance (average review time: 153 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
LFH devices are reviewed by the Toxicology panel. Browse all Toxicology devices →