DNIClass II

Liquid Chromatography, Amphetamine

21 CFR 862.3100 / Clinical Toxicology

DNI is the FDA product code for Liquid Chromatography, Amphetamine, a class II device type, regulated under 21 CFR 862.3100. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1995-03-27, and no recalls.

Classification record

Product code: DNI
Device name: Liquid Chromatography, Amphetamine
Regulation: 21 CFR 862.3100
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code DNI

By decision year

1 clearance under product code DNI with a decision year between 1995 and 1995, 1995 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code DNI by decision year
Year	Clearances
1995	1

Applicants with the most clearances

Product code DNI

Applicants holding the most 510(k) clearances under product code DNI
Applicant	Clearances
Bio-Rad	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code DNI

K941596Class IIRemedi Hs Drug Profiling SystemBio-Rad / cleared 1995-03-27

Recent recalls

Product code DNI

FDA records show no recalls under product code DNI.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)