LPJ — Kit, Assay, Estrogen Receptor Class III

FDA Device Classification

FDA product code LPJ covers "Kit, Assay, Estrogen Receptor", a Class III medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel.

Classification Details

Product Code
LPJ
Device Class
Class III
Regulation Number
864.1860
Submission Type
Review Panel
CH
Medical Specialty
Hematology
Implant
No