DGK — Igg, Fitc, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DGK covers "Igg, Fitc, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5510. 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
DGK
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
K831908dakoRABBIT ANTISERUM TO HUMAN IGGJuly 18, 1983
K831609intl. diagnostic technologyFIAX IGG TEST KITJune 17, 1983