HZEClass I

Nile Blue

21 CFR 864.1850 / Hematology

HZE is the FDA product code for Nile Blue, a class I device type, regulated under 21 CFR 864.1850. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: HZE
Device name: Nile Blue
Regulation: 21 CFR 864.1850
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

ENG Scientific LLC

Recent clearances

Product code HZE

FDA records hold no clearances under product code HZE.

Recent recalls

Product code HZE

FDA records show no recalls under product code HZE.

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)