JNE — Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase Class I

FDA Device Classification

FDA product code JNE covers "Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase", a Class I medical device regulated under 21 CFR 862.1570. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JNE
Device Class
Class I
Regulation Number
862.1570
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No