LJD — Assay, B Lymphocyte Marker Class II

FDA Device Classification

FDA product code LJD covers "Assay, B Lymphocyte Marker", a Class II medical device regulated under 21 CFR 864.5220. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
LJD
Device Class
Class II
Regulation Number
864.5220
Submission Type
Review Panel
IM
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K851639bd becton dickinson vacutainer systems preanalyticANTI-LEU-12 B CELL REAGENTJuly 2, 1986