DLEClass II

Reagents, Test, Bromides

21 CFR 862.3645 / Clinical Toxicology

DLE is the FDA product code for Reagents, Test, Bromides, a class II device type, regulated under 21 CFR 862.3645. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: DLE
Device name: Reagents, Test, Bromides
Regulation: 21 CFR 862.3645
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: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DLE.

Recent clearances

Product code DLE

FDA records hold no clearances under product code DLE.

Recent recalls

Product code DLE

FDA records show no recalls under product code DLE.

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)