LFI — High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs Class II

FDA Device Classification

FDA product code LFI covers "High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs", a Class II medical device regulated under 21 CFR 862.3910. Submissions are reviewed by the Clinical Toxicology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LFI
Device Class
Class II
Regulation Number
862.3910
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K941994bio-radBENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLCMarch 20, 1995
K941990bio-radBENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLCMarch 20, 1995
K934340biosite incorporatedBIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSDecember 2, 1994
K802245technicon instruments7 TRICYCLIC ANTIDE PRESSANTSOctober 10, 1980