IGK — Solution, Clarke'S Class I

FDA Device Classification

FDA product code IGK covers "Solution, Clarke'S", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel.

Classification Details

Product Code
IGK
Device Class
Class I
Regulation Number
864.4010
Submission Type
Review Panel
HE
Medical Specialty
Pathology
Implant
No