KEP — Media, Mounting, Oil Soluble Class I

FDA Device Classification

FDA product code KEP covers "Media, Mounting, Oil Soluble", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KEP
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
K830659surgipath medical industriesCLEARIUM, MOUNTING MEDIUMMarch 17, 1983
K810323surgipathACRYTOL, MOUNTING MEDIUMMarch 6, 1981
K800847mcb manufacturing chemistsENTELLANMay 8, 1980