DDI — Transferrin, Fitc, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DDI covers "Transferrin, Fitc, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5880. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DDI
Device Class
Class II
Regulation Number
866.5880
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K842071intl. diagnostic technologyFIAX TRANSFERRIN TEST KITJuly 11, 1984
K772074gelman instrumentRADIAL IMMUNODIFFUSION KIT-TRANSFERRINFebruary 3, 1978