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KJP — Carmine Class I

FDA Device Classification

FDA product code KJP covers "Carmine", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel.

Classification Details

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