DBJ — Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control Class II

FDA Device Classification

FDA product code DBJ covers "Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control", a Class II medical device regulated under 21 CFR 866.5110. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DBJ
Device Class
Class II
Regulation Number
866.5110
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K930422elias u.s.aSYNELISA PARIETAL CELL ANTIBODIESAugust 3, 1993
K790759medicaIIF-APCA TEST KITJuly 30, 1979