DFK — Igg (Fab Fragment Specific), Antigen, Antiserum, Control Class I

FDA Device Classification

FDA product code DFK covers "Igg (Fab Fragment Specific), Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5520. 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
DFK
Device Class
Class I
Regulation Number
866.5520
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K790711kent laboratoriesANTISERA TO HUMAN FRAGMENTSeptember 4, 1979
K771243kent laboratoriesANTISERA TO HUMAN FAB FRAGMENTAugust 3, 1977
K770670kent laboratoriesFLOR. CONJUG. HUMAN FAB FRAGMENTApril 28, 1977