DAY — Complement C5, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DAY covers "Complement C5, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5240. 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
DAY
Device Class
Class II
Regulation Number
866.5240
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K942326jay h. gellerHUMAN C5 RID KITSAugust 24, 1995
K950102kent laboratoriesHUMAN C-5 RADIAL IMMUNODIFFUSION KITApril 10, 1995
K772075gelman instrumentRADIAL IMMUNODIFFUSION KIT-COMPLEMENTFebruary 3, 1978