JBW — Red-Cell Indices, Measured Class II

FDA Device Classification

FDA product code JBW covers "Red-Cell Indices, Measured", a Class II medical device regulated under 21 CFR 864.5300. Submissions are reviewed by the Hematology panel.

Classification Details

Product Code
JBW
Device Class
Class II
Regulation Number
864.5300
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No