KJE — Spinner System, Cell Culture Class I

FDA Device Classification

FDA product code KJE covers "Spinner System, Cell Culture", a Class I medical device regulated under 21 CFR 864.2240. Submissions are reviewed by the Hematology panel.

Classification Details

Product Code
KJE
Device Class
Class I
Regulation Number
864.2240
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No