KEL — Adhesive, Albumin-Based Class I

FDA Device Classification

FDA product code KEL covers "Adhesive, Albumin-Based", a Class I medical device regulated under 21 CFR 864.4010. 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
KEL
Device Class
Class I
Regulation Number
864.4010
Submission Type
Review Panel
PA
Medical Specialty
Pathology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K890022alpha-tec systemsATS MAYER'S ALBUMINJanuary 10, 1989
K881477stat pathHISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTEDApril 18, 1988