JLIClass I

Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid

21 CFR 862.1305 / Clinical Chemistry

JLI is the FDA product code for Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid, a class I device type, regulated under 21 CFR 862.1305. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: JLI
Device name: Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid
Regulation: 21 CFR 862.1305
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Immunocentrix Corporation

Recent clearances

Product code JLI

FDA records hold no clearances under product code JLI.

Recent recalls

Product code JLI

FDA records show no recalls under product code JLI.

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)