DMN — Thin Layer Chromatography, Cocaine Class II

FDA Device Classification

FDA product code DMN covers "Thin Layer Chromatography, Cocaine", a Class II medical device regulated under 21 CFR 862.3250. Submissions are reviewed by the Clinical Toxicology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DMN
Device Class
Class II
Regulation Number
862.3250
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K972618phamatechQUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)August 8, 1997
K874389sakersCRACK-IT CHAP SCREENFebruary 7, 1989