KTK — Reagent, Immunoassay, Carbonic Anhydrase B And C Class I

FDA Device Classification

FDA product code KTK covers "Reagent, Immunoassay, Carbonic Anhydrase B And C", a Class I medical device regulated under 21 CFR 866.5200. Submissions are reviewed by the Immunology panel.

Classification Details

Product Code
KTK
Device Class
Class I
Regulation Number
866.5200
Submission Type
Review Panel
HE
Medical Specialty
Immunology
Implant
No