JLO — Enzymatic (Glutathione Reductase), Glutathione Class I

FDA Device Classification

FDA product code JLO covers "Enzymatic (Glutathione Reductase), Glutathione", a Class I medical device regulated under 21 CFR 862.1365. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JLO
Device Class
Class I
Regulation Number
862.1365
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No