LGLClass II

Assay, Bart'S, Hemoglobin

21 CFR 864.7500 / Hematology

LGL is the FDA product code for Assay, Bart'S, Hemoglobin, a class II device type, regulated under 21 CFR 864.7500. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1981-05-29, and no recalls.

Classification record

Product code: LGL
Device name: Assay, Bart'S, Hemoglobin
Regulation: 21 CFR 864.7500
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code LGL

By decision year

2 clearances under product code LGL with a decision year between 1981 and 1981, 1981 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code LGL by decision year
Year	Clearances
1981	2

Applicants with the most clearances

Product code LGL

Applicants holding the most 510(k) clearances under product code LGL
Applicant	Clearances
Isolab, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code LGL

Recent recalls

Product code LGL

FDA records show no recalls under product code LGL.

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)