JLI — Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid Class I

FDA Device Classification

FDA product code JLI covers "Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid", a Class I medical device regulated under 21 CFR 862.1305. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JLI
Device Class
Class I
Regulation Number
862.1305
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No