FDA Product Code LFH: U.v. Spectrometry, Tricyclic Antidepressant Drugs
Leading manufacturers include Microgenics Corporation, Diagnostic Reagents, Inc. and Abbott Laboratories.
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
Cleared
Nov 18, 1998
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
Diagnostic Reagents, Inc.
Toxicology
62d
Cleared
Aug 25, 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
Princeton BioMeditech Corp.
Toxicology
96d
Cleared
Jun 12, 1996
TRICYCLICS SERUM TOX ASSAY
Diagnostic Reagents, Inc.
Toxicology
62d
Cleared
Nov 22, 1995
AXSYM TRICYCLIC ANTIDEPRESSANTS
Abbott Laboratories
Toxicology
103d
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.