DFL — Igm, Ferritin, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DFL covers "Igm, Ferritin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5550. 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
DFL
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
K883493technicon instrumentsTECHNICON DPA-1 IMMUNOGLOBULIN MSeptember 22, 1988
K882822cyberfluorFIAGEN FERRITINAugust 4, 1988
K772079gelman instrumentRADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.MFebruary 3, 1978