DAN — Fibrinopeptide A, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DAN covers "Fibrinopeptide A, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5350. 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
DAN
Device Class
Class II
Regulation Number
866.5350
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K884496altanaRIA/MAT FPA TEST KITNovember 16, 1988
K854384american bioproductsASSERACHROM FPA KITFebruary 4, 1986
K821151mallinckrodt critical careRIA-QUANT FPA TEST KITJuly 22, 1982