DEY — Igm, Peroxidase, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DEY covers "Igm, Peroxidase, 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
DEY
Device Class
Class II
Regulation Number
866.5550
Submission Type
Review Panel
PA
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K932386ventana medical systemsVENTANA RED DETECTION KITAugust 9, 1993
K920600ventana medical systemsDAB DETECTION KITMay 11, 1992
K920566ventana medical systemsAEC DETECTION KITMay 8, 1992