JBK — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic Class II

FDA Device Classification

FDA product code JBK covers "Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic", a Class II medical device regulated under 21 CFR 864.7360. Submissions are reviewed by the Hematology panel.

Classification Details

Product Code
JBK
Device Class
Class II
Regulation Number
864.7360
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No