DAB — Haptoglobin, Fitc, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DAB covers "Haptoglobin, Fitc, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5460. 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
DAB
Device Class
Class II
Regulation Number
866.5460
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K913670binding siteHAPTOGLOBIN IMMUNOLOGICAL TEST KITDecember 9, 1991
K843570intl. diagnostic technologyFIAX HAPTOGLOBIN TEST KITOctober 5, 1984
K772078gelman instrumentRADIAL IMMUNODIFFUSION KIT-HAPTOGLOBINFebruary 3, 1978