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DEO — Kappa, Fitc, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DEO covers "Kappa, Fitc, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5550. 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
DEO
Device Class
Class II
Regulation Number
866.5550
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K832260gelco diagnosticsGOAT ANTI-HUMAN KAPPA AFFINITYOctober 31, 1983
K831904dakoRABBIT ANTISERUM TO HUMAN KAPPA LIGHTJuly 19, 1983

FDA data resources