LIJ — Peroxidase Anti-Peroxidase Immunohistochemical Stain Class I

FDA Device Classification

FDA product code LIJ covers "Peroxidase Anti-Peroxidase Immunohistochemical Stain", a Class I medical device regulated under 21 CFR 864.4400. Submissions are reviewed by the Pathology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LIJ
Device Class
Class I
Regulation Number
864.4400
Submission Type
Review Panel
PA
Medical Specialty
Pathology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K855034bartels immunodiagnostic suppliesAMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANTMarch 11, 1986
K820336dakoDAKO PAP KIT K509July 13, 1982