JHH — Electrophoretic Method, Lecithin/Sphingomyelin Ratio Class II

FDA Device Classification

FDA product code JHH covers "Electrophoretic Method, Lecithin/Sphingomyelin Ratio", a Class II medical device regulated under 21 CFR 862.1455. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JHH
Device Class
Class II
Regulation Number
862.1455
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No