JLY — Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid Class I

FDA Device Classification

FDA product code JLY covers "Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid", a Class I medical device regulated under 21 CFR 862.1255. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JLY
Device Class
Class I
Regulation Number
862.1255
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No