HYR — Leuco-Patent Blue Class I

FDA Device Classification

FDA product code HYR covers "Leuco-Patent Blue", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel.

Classification Details

Product Code
HYR
Device Class
Class I
Regulation Number
864.1850
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No