DGD — Igg, Ferritin, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DGD covers "Igg, Ferritin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DGD
Device Class
Class II
Regulation Number
866.5510
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K946266clinical controlsFERRITIN CONTROL - LEVEL 1, 2, 3February 10, 1995
K881345abbott laboratoriesIMX FERRITINMay 11, 1988
K830229mallinckrodt critical careROENTGENOGRAPHY SETMarch 9, 1983