LPJClass III

Kit, Assay, Estrogen Receptor

21 CFR 864.1860 / Hematology

LPJ is the FDA product code for Kit, Assay, Estrogen Receptor, a class III device type, regulated under 21 CFR 864.1860. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: LPJ
Device name: Kit, Assay, Estrogen Receptor
Regulation: 21 CFR 864.1860
Device class: Class III
Review panel: Hematology
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code LPJ

FDA records hold no clearances under product code LPJ.

Recent recalls

Product code LPJ

Z-1627-2024Class IIThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shellHowmedica Osteonics Corp. / initiated 2024-02-27 / 0

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)